CAPIRI-IMRT: a phase II study of concurrent capecitabine and irinotecan with intensity-modulated radiation therapy for the treatment of recurrent XXXX .

@entity1 @entity137 @entity5 @entity294 @entity1431 @entity3
BACKGROUND: This study investigated the local effect and acute @entity137 of irinotecan and capecitabine with concurrent intensity-modulated radiation therapy (IMRT) for the treatment of recurrent @entity5 without prior pelvic irradiation. METHODS: Seventy-one @entity1 diagnosed with recurrent @entity5 who did not previously receive pelvic irradiation were treated in our hospital from October 2009 to July 2012. Radiotherapy was delivered to the pelvis, and IMRT of 45  Gy (1.8  Gy per fraction), followed by a boost of 10  Gy to 16  Gy (2  Gy per fraction), was delivered to the recurrent sites. The concurrent chemotherapy regimen was 50  mg/m(2) irinotecan weekly and 625  mg/m(2) capecitabine twice daily (Mon-Fri). Radical surgery was recommended for medically fit @entity1 without extra-pelvic @entity3 . The @entity1 were followed up every 3  months. @entity5 response was evaluated using CT/MRIs according to the RECIST criteria or postoperative pathological findings. NCI-CTC 3.0 was used to score the @entity137 . RESULTS: Forty-eight @entity1 (67.6%) had confirmed recurrent @entity5 without extra pelvic @entity3 , and 23 @entity1 (32.4%) had extra pelvic @entity3 . Fourteen @entity1 (19.7%) underwent radical resections (R0) post-chemoradiation. A pathologic complete response was observed in 7 of 14 @entity1 . A clinical complete response was observed in 4 @entity1 (5.6%), and a partial response was observed in 22 @entity1 (31.0%). Only 5 @entity1 (7.0%) showed progressive disease during or shortly after treatment. Of 53 symptomatic @entity1 , clinical complete and partial symptom relief with chemoradiation was achieved in 56.6% and 32.1% of @entity1 , respectively. Only 2 @entity1 (2.8%) experienced grade 4 @entity1431 . The most common grade 3 @entity137 was @entity294 (16 [22.5%] @entity1 ). The median follow-up was 31  months. The cumulative local progression-free survival rate was 74.2% and 33.9% at 1 and 3  years after chemoradiation, respectively. The cumulative total survival rate was 80.1% and 36.5% at 1 and 3  years after chemoradiation, respectively. CONCLUSIONS: This study revealed that concurrent irinotecan and capecitabine with IMRT significantly relieves local symptoms and exhibits promising efficacy with manageable @entity137 in recurrent @entity5 without prior pelvic irradiation. Improving the rate of R0 resections will be investigated in a future study.
