Chemotherapy, Metastasis, Nasopharyngeal Carcinoma, Survival
Conditions
Brief summary
The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Thus, we sought to find an efficient chemotherapy regimen with high tolerance according to the characteristics of chemotherapy drugs, that is, to explore the efficacy and safety of platinum plus 5-fluorouracil with continuous intravenous infusion at a low dose for a long term.
Detailed description
Nasopharyngeal carcinoma (NPC) is a malignant tumor of the nasopharyngeal epithelium with high sensitivity to ionizing radiation. With the use of intensive chemoradiotherapy, excellent treatment outcomes can be achieved for local control, but disease failure was observed in approximately 20% of patients. Moreover, approximately 10% of newly diagnosed patients diagnosed with metastasis, resulting in about 30% of NPC patients will present with either synchronous or metachronous metastasis in total. Chemotherapy is the cornerstone of the treatment of metastatic NPC. Many studies were aimed at the systemic treatment of metastatic NPC, but most of them were retrospective studies or phase II trials with small samples. The outcome of metastatic NPC is poor with a median OS of about 20 months. Platinum-containing doublet chemotherapy is generally regarded as the standard treatment for metastatic NPC. After a multicenter phase III randomized clinical trial was published in 2016, gemcitabine plus cisplatin is recommended, however, less than 60% of patients could complete the treatment in the trail. Finding a proper regimen with promising efficacy results as well as high tolerance is still a big challenge. Cisplatin plus 5-fluorouracil (PF) is a classical regimen widely used in metastatic NPC. The continuous infusion of 5-fluorouracil with low dose was investigated in esophagus carcinoma, rectal carcinoma and prostate carcinoma with encouraging outcome and acceptable toxicity. Whereas, data of platinum-containing chemotherapy with low-dose continuous infused 5-fluorouracil in metastatic NPC was absent. In this study, we aimed to investigate the antitumor activity of platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil (PFLL).
Interventions
None listed
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Nasopharyngeal carcinoma diagnosed by pathology or cytology * Distant metastasis confirmed by Radiographic assessments or pathology. * Patients ever received systemic chemotherapy.
Exclusion criteria
* Age \<18 or \>70 years old * Pathologic type unknown or except type I-III of World Health Organization classification * Never underwent platinum-based chemotherapy * Lack of information about T classification and N classification when metastasis * Lost follow-up within one month from the start of treatment for metastasis * Without other malignances
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival | 5 years after diagnosis of metastasis | The period until death is detected. |
| 5-year subsequent-line treatment-free survival | 5 years after the start of the first-line treatment | The period until earliest of the start date of subsequent-line treatment or death is detected. |
| 5-year survival without symptoms and toxicity | 5 years after diagnosis of metastasis | The period until any events (death or disease progression or ≥grade 3 chemotherapy-related haematological toxicity) is detected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haematological toxicity | From the start of the first-line treatment, evaluation was performed every cycle during the treatment and then every 3-6 months after the completion of the treatment, up to the start of subsequent-line treatment or death or 5 years. | The incidence of myelosuppression |
Countries
China
Contacts
Primary ContactYun-fei Xia, MD
Backup ContactShuo-han Zheng, MD
Outcome results
None listed