Journal
AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS
Volume 46, Issue 7, Pages 293-299Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/COC.0000000000001007
Keywords
anal cancer; toxicity; radiation therapy; proton therapy; feasibility; patient-reported outcomes
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The purpose of this trial was to evaluate the toxicity reported by patients and physicians in anal cancer patients undergoing chemoradiation with intensity-modulated proton therapy. The results showed that there was no significant difference in physician-reported gastrointestinal, genitourinary, dermatologic, and hematologic toxicity between patients treated with intensity-modulated proton therapy and those treated with intensity-modulated radiotherapy. However, high-grade gastrointestinal symptoms persisted for 12 months and additional measures are needed to minimize toxicity related to chemoradiation.
Purpose:The purpose of this trial was to assess the patient and physician-reported toxicity in anal cancer patients undergoing definitive chemoradiation with intensity-modulated proton therapy (IMPT). Methods:Patients with stage II and III anal cancer were treated with IMPT. All patients received 2 cycles of 5-fluorouracil and mitomycin concurrently with radiation. Toxicity was assessed at baseline, weekly during chemoradiation, and in follow-up using physician-graded common terminology criteria for adverse events (CTCAE) v 4.0 and PRO-CTCAE. The primary endpoint was to define point estimates and 95% CI for acute & GE; grade 2/3 gastrointestinal (GI), genitourinary (GU), dermatologic, and hematologic toxicity. The proportion of PRO-CTCAE questions scored & GE;3 for each domain was compared with the baselinse. The proportion of & GE; grade 2 and & GE; grade 3 toxicities were compared with historic intensity-modulated radiotherapy patients treated on RTOG 0529. Results:Fourteen patients were enrolled from 2017 to 2020. Rates of physician-reported GI, GU, dermatologic, and hematologic toxicity were not significantly different between patients treated with IMPT compared with patients treated with intensity-modulated radiotherapy. Rates of patient-reported dermatologic and GU toxicity were low at baseline with a peak at week 6 (91% and 58% PRO-CTCAE items & GE; grade 3, respectively) and normalization to baseline 3 months after IMPT. In contrast, the proportion of high-grade PRO-CTCAE GI scores was 40% at baseline, which persisted through 1-year posttreatment. Conclusions:Clinician-reported toxicity was not improved with IMPT in the context of this underpowered trial. High-grade GI symptoms persisted for 12 months and were similar to baseline. Additional measures are needed to minimize acute and chronic toxicity related to chemoradiation.
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