Lymphoma
Conditions
Keywords
stage I adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
Brief summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma.
Detailed description
OBJECTIVES: Primary * To assess the 5-year progression-free survival (PFS) rate in patients with newly diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission tomography (PET)/CT scan to direct therapy after 3 courses of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP). Secondary * To evaluate PFS within the PET-positive (+) and PET-negative (-) subgroups of patients with newly diagnosed limited-stage DLBCL. * To evaluate toxicity of the protocol treatments in this patient population. * To evaluate the response probability in this patient population. * To evaluate overall survival in the overall population, and within the PET+ and PET- subgroups. * To estimate the rate of upstaging at baseline by PET/CT at baseline among patients newly diagnosed with limited-stage DLBCL by CT imaging and to describe outcomes in patients upstaged by PET/CT at baseline to advanced DLBCL. * To describe outcomes in the subgroup of patients upstaged by PET/CT. * To evaluate the association of germinal center B-cell subtype (GCB) vs stromal-1 vs stromal-2 gene expression signatures with PFS or overall survival. OUTLINE: This is a multicenter study. Patients are stratified according to whether the patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT (yes vs no). Chemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over 30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and prednisone orally on days 1-5. Treatment repeats every 21 days for 3\* courses. NOTE: \*Patients found to have advanced stage DLBCL based on local review of the baseline PET scan receive 6 courses of R-CHOP. FDG/PET - Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion of course 3. Patients with complete response (PET scan negative) receive one additional course of R-CHOP as above. Patients with partial response (PET scan positive) undergo involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks. Monoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or 9. Patients may undergo blood sample collection at baseline for correlative studies. Bone marrow tissue samples may be also collected for correlative studies. After completion of study therapy, patients are followed up every 6 months for 2 years and then yearly for 5 years.
Interventions
BIOLOGICALrituximab
DRUGcyclophosphamide
DRUGdoxorubicin hydrochloride
DRUGprednisone
DRUGvincristine sulfate
OTHERR-CHOP regimen
OTHERlaboratory biomarker analysis
RADIATIONfludeoxyglucose F 18
RADIATIONselective external radiation therapy
RADIATIONyttrium Y 90 ibritumomab tiuxetan
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL) * Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group * Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections * Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible * Patients must have non-bulky stage I or II disease by Ann Arbor classification * This staging excludes FDG-PET evaluation * Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible * Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration * Low-resolution localization CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol * If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable * Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma * Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration * Patients may have either measurable or evaluable limited-stage DLBCL * Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible * If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187) * All measurable disease must be assessed within 28 days prior to registration * Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration * Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Absolute neutrophil count (ANC) ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome) * Patients must not be pregnant or nursing * Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period * Patients must not be known to be HIV-positive * No other prior malignancy is allowed except for the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I or II cancer from which the patient is currently in complete remission * Any other cancer from which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: * Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL) | up to 5 years | Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion \>1.5 cm in the longest axis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) | up to 5 years | Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | up to 4 months or time of disease progression. | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. |
| Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) | up to 5 years | Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP | Up to 4 months | Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site. |
| Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival. | 5 years | Formalin-fixed, paraffin-embedded tissue from the diagnostic biopsy is collected and used to determine germinal center B-cell (GCB) phenotype. GCB subtype of DLBCL is defined by gene-expression profiling that is performed using quantitative nuclease protection assay (qNPA). Data for this outcome measure is not available at this time. We expect this data to be available by December 2025. |
Countries
United States
Participant flow
Recruitment details
Patients with nonbulky (\< 10 cm) stage I/II untreated DLBCL received 3 cycles of standard R-CHOP therapy and underwent a centrally reviewed interim PET/computed tomography scan (iPET). Those with a negative iPET proceeded with 1 additional cycle of R-CHOP, whereas those with a positive iPET received involved field radiation therapy followed by ibritumomab tiuxetan radioimmunotherapy.
Participants by arm
| Arm | Count |
|---|---|
| R-CHOP x 3 Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP
For each cycle, R-CHOP therapy included:
Rituximab: 375 mg/m\^2 IV administration on Day 1
Cyclophosphamide: 750 mg/m\^2 IV administration on Day 1
Doxorubicin: 50 mg/m\^2 IV administration on Day 1
Vincristine: 1.4 mg/m\^2 (maximum 2 mg) IV administration on Day 1
Prednisone: 100 mg administered orally on Days 1 through 5 | 132 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Initial Registration | Adverse Event | 1 | 0 | 0 | 0 |
| Initial Registration | Death | 1 | 0 | 0 | 0 |
| Initial Registration | Ineligible | 26 | 0 | 0 | 0 |
| Initial Registration | Other reason not protocol specified | 1 | 0 | 0 | 0 |
| PET-Directed Therapy | Adverse Event | 0 | 0 | 1 | 0 |
| PET-Directed Therapy | Ineligible | 0 | 0 | 24 | 0 |
| PET-Directed Therapy | Refusal unrelated to adverse event | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | R-CHOP x 3 |
|---|---|
| Age, Continuous | 62 years |
| Age, Customized Age <= 60 years | 61 Participants |
| Age, Customized Age > 60 years | 71 Participants |
| Cell of Origin by Lymph2Cx ABC | 20 Participants |
| Cell of Origin by Lymph2Cx GCB | 59 Participants |
| Cell of Origin by Lymph2Cx Unclassifiable | 8 Participants |
| Double protein expressors (DPE) DPE | 21 Participants |
| Double protein expressors (DPE) Indeterminate | 5 Participants |
| Double protein expressors (DPE) Non-DPE | 97 Participants |
| Elevated Lactate Dehydrogenase (LDH) No | 113 Participants |
| Elevated Lactate Dehydrogenase (LDH) Yes | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Extranodal Involvement No | 75 Participants |
| Extranodal Involvement Yes | 57 Participants |
| Histologic Subtype Central pathologic review not performed | 9 Participants |
| Histologic Subtype Diffuse large B-cell lymphoma, NOS | 95 Participants |
| Histologic Subtype High-grade B-cell lymphoma, NOS | 22 Participants |
| Histologic Subtype High-grade B-cell lymphoma with MYC and BCL2 or/and BCL6 rearrangements | 4 Participants |
| Histologic Subtype T cell/histiocyte-rich large B-cell lymphoma | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 115 Participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 70 Participants |
| Stage Stage I | 82 Participants |
| Stage Stage II | 50 Participants |
| Stage-modified International Prognostic Index risk factors 0 | 35 Participants |
| Stage-modified International Prognostic Index risk factors 1 | 55 Participants |
| Stage-modified International Prognostic Index risk factors 2 | 37 Participants |
| Stage-modified International Prognostic Index risk factors 3 | 5 Participants |
| Symptoms A | 109 Participants |
| Symptoms B | 23 Participants |
| Zubrod Performance Status 0 | 89 Participants |
| Zubrod Performance Status 1 | 39 Participants |
| Zubrod Performance Status 2 | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 132 | 0 / 1 | 1 / 113 | 0 / 12 |
| other Total, other adverse events | 130 / 132 | 1 / 1 | 105 / 113 | 11 / 12 |
| serious Total, serious adverse events | 2 / 132 | 0 / 1 | 2 / 113 | 0 / 12 |
Outcome results
Primary
Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion \>1.5 cm in the longest axis.
Time frame: up to 5 years
Population: Eligible and evaluable patients were included in the analysis. The patient who was upstaged at baseline by PET/CT was not included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R-CHOP x 3 Followed by PET-directed Therapy | Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL) | 87 percentage of participants |
Secondary
Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival.
Formalin-fixed, paraffin-embedded tissue from the diagnostic biopsy is collected and used to determine germinal center B-cell (GCB) phenotype. GCB subtype of DLBCL is defined by gene-expression profiling that is performed using quantitative nuclease protection assay (qNPA). Data for this outcome measure is not available at this time. We expect this data to be available by December 2025.
Time frame: 5 years
Secondary
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time frame: up to 4 months or time of disease progression.
Population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyponatremia | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary tract infection | 3 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Catheter related infection | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophil count decreased | 34 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukemia secondary to oncology chemotherapy | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nervous system disorders - Other, specify | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lung infection | 2 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphocyte count decreased | 16 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thromboembolic event | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 2 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | White blood cell decreased | 26 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea | 3 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Stroke | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema limbs | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bone pain | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Endocrine disorders - Other, specify | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Skin infection | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fall | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alanine aminotransferase increased | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue | 3 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sepsis | 2 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 13 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Generalized muscle weakness | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Resp, thoracic and mediastinal disorders - Other | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperglycemia | 3 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | CD4 lymphocytes decreased | 1 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelet count decreased | 5 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypocalcemia | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypokalemia | 2 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anemia | 7 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Peripheral sensory neuropathy | 1 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | White blood cell decreased | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Skin infection | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyponatremia | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Peripheral sensory neuropathy | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophil count decreased | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Endocrine disorders - Other, specify | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypokalemia | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperglycemia | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Catheter related infection | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nervous system disorders - Other, specify | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fall | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukemia secondary to oncology chemotherapy | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anemia | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary tract infection | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sepsis | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lung infection | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thromboembolic event | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelet count decreased | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphocyte count decreased | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alanine aminotransferase increased | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypocalcemia | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Stroke | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bone pain | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Resp, thoracic and mediastinal disorders - Other | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | CD4 lymphocytes decreased | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Generalized muscle weakness | 0 Participants |
| Interim PET-positive | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema limbs | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema limbs | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alanine aminotransferase increased | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anemia | 2 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bone pain | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | CD4 lymphocytes decreased | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Catheter related infection | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Endocrine disorders - Other, specify | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fall | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 2 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Generalized muscle weakness | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperglycemia | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypocalcemia | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypokalemia | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyponatremia | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 2 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukemia secondary to oncology chemotherapy | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lung infection | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphocyte count decreased | 9 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nervous system disorders - Other, specify | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophil count decreased | 11 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Peripheral sensory neuropathy | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelet count decreased | 4 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Resp, thoracic and mediastinal disorders - Other | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sepsis | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Skin infection | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Stroke | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thromboembolic event | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary tract infection | 0 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 1 Participants |
| PET-negative: R-CHOP x 1 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | White blood cell decreased | 12 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypocalcemia | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bone pain | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Peripheral sensory neuropathy | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperglycemia | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alanine aminotransferase increased | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelet count decreased | 3 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Generalized muscle weakness | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary tract infection | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Resp, thoracic and mediastinal disorders - Other | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fall | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sepsis | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Endocrine disorders - Other, specify | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema limbs | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | White blood cell decreased | 2 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Skin infection | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Stroke | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Catheter related infection | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphocyte count decreased | 2 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lung infection | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anemia | 1 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukemia secondary to oncology chemotherapy | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thromboembolic event | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nervous system disorders - Other, specify | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyponatremia | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | CD4 lymphocytes decreased | 0 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophil count decreased | 2 Participants |
| PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypokalemia | 0 Participants |
Secondary
Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time frame: up to 5 years
Population: Eligible and evaluable patients were included in the analysis. The patient who was upstaged at baseline by PET/CT was not included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R-CHOP x 3 Followed by PET-directed Therapy | Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) | 89 percentage of participants |
Secondary
Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.
Time frame: up to 5 years
Population: Eligible and evaluable patients who had interim PET/CT performed were included in the analysis. The patient who was upstaged at baseline by PET/CT was not included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R-CHOP x 3 Followed by PET-directed Therapy | Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) | 89 percentage of participants |
| Interim PET-positive | Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) | 86 percentage of participants |
Secondary
Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Time frame: Up to 4 months
Population: Eligible and evaluable patients who treated with PET-directed therapy based on FDG-PET imaging after 3 cycles of R-CHOP were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| R-CHOP x 3 Followed by PET-directed Therapy | Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP | Complete Response | 112 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP | Partial Response | 0 Participants |
| R-CHOP x 3 Followed by PET-directed Therapy | Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP | Inadequate Assessment | 1 Participants |
| Interim PET-positive | Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP | Complete Response | 8 Participants |
| Interim PET-positive | Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP | Partial Response | 4 Participants |
| Interim PET-positive | Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP | Inadequate Assessment | 0 Participants |