Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix

Acute radiation side effects were prospectively assessed. Below are the treatment-related acute toxicities (adverse events possibly, probably, or definitely related to protocol treatment that started within 4 weeks of treatment completion) that occurred on study, along with the number of participants who experienced each event at a given severity (Grade 1/mild, Grade 2/moderate, Grade 3/severe) according to the CTCAE v 4.02 (Common terminology criteria for adverse events).

Time frame: 10 weeks

Population: 22 patients enrolled, 1 of whom discontinued prior to study treatment. The remaining 21 patients were analyzed.

Delayed complications from radiation were prospectively assessed. Below are the treatment-related late toxicities (adverse events possibly, probably, or definitely related to protocol treatment that started 6 months or later after treatment completion) that occurred on study, along with the number of participants who experienced each event at a given severity (Grade 1/mild, Grade 2/moderate, Grade 3/severe) according to the CTCAE v 4.02 (Common terminology criteria for adverse events).

Time frame: 5 years

Population: 22 subjects enrolled, and 1 subject withdrew consent prior to treatment. The remaining 21 subjects were analyzed.

In a population of women with cancers of the cervix or endometrium with pathologically proven spread to regional lymph nodes, dose volume histograms (DVH) were compared between scanning proton beam teletherapy, 3-dimensional conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT). Structure sets contoured for the proton beam therapy delivered on study were used to plan alternative 3DCRT and IMRT plans by the the same medical physics team (3DCRT and IMRT were not used on study; actual dose for proton beam was compared to the doses that would have been delivered for 3DCRT or IMRT.) Median, 25th percentile, and 75th percentile doses are listed below by tissue volume irradiated (mL) or percentage irradiated (%) for each modality. Dose is measured in grays (Gy), which is defined as the absorption of one joule of radiation energy per kilogram of matter.

Time frame: 5 years

Population: 22 patients enrolled, 1 of whom withdrew consent prior to study treatment. Remaining 21 patients were included in the final analysis.

PFS is defined as the duration of time from start of treatment to time of objective disease progression at any site as detected by symptomatic recurrence or routine surveillance follow-up physical examination/imaging, or death from any cause.

Time frame: 12 months, 24 months, 36 months, 48 months, and 60 months

Population: 22 patients were enrolled, 1 of whom withdrew prior to study treatment. The remaining 21 patients were included in this analysis.

The total FACT-EN/Cx scale (Functional Assessment of Cancer Therapy - Endometrial/Cervical) score was assessed at baseline and timepoints of 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years to evaluate quality of life (QOL) before and after adjuvant scanning proton beam therapy. Unit = Scores on a scale. Subset scores are summed together to get a total score. Functional Assessment of Cancer Therapy - Endometrial - score range 0 - 172, with higher scores indicating a better outcome Functional Assessment of Cancer Therapy - Cervical - score range 0 - 168, with higher scores indicating a better outcome

Time frame: Baseline, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

Population: 22 patients were enrolled, 1 of whom withdrew consent prior to study treatment. The remaining 21 subjects were analyzed.