Neoadjuvant capecitabine, oxliplatin, and bevacizumab (CAPOX-B) in intermediate-risk rectal cancer (RC) patients defined by magnetic resonance (MR): GEMCAD 0801 trial.

Abstract

3586 Background: Retrospective data suggest that RT might not be needed in all patients with stage II/III RC. Modern systemic therapy might have local efficacy similar to chemoradiation (CRT). Methods: A multicenter phase II trial was undertaken to evaluate safety and efficacy of neoadjuvant CAPOX-B in patients with T3 middle third rectal adenocarcinoma. Eligible patients (pts) had measurable disease at the baseline and candidate for R0 total mesorectal escision (TME) with intermediate-risk defined by pelvic MR a) T3 with distal border of tumor > 5 cm from the anal verge and below the sacral promontory. b) tumor ≥2 mm from the mesorectal fascia. Pts received 4 cycles of Cap 2000 mg/m2 (d1-14), Ox 130 mg/m2 (d1) and B 7.5 mg/kg (d1) every 3 weeks (last cycle without B). Pts undergo re-staging with MR. One radiologist reviewed all pre- and post-treatment MR scans independently. Pts without progression proceed to TME 4-6 weeks from the last cycle. If progression, pts were to be referred for pre-op cap/RT followed by TME. 1º Endpoint: Tumor Response (RECIST). Design: Simon 2-stage; 28 pts 1st stage and 46 pts 2nd stage. We report data on the planned analysis of pts included for 1st stage. Results: 28 eligible pts (10F/18M) were enrolled from 7/09-5/11. Tumor response, compliance and toxicity details are shown in table below. Two pN2 pts received postop Cap/RT. Conclusions: Neoadjuvant CAPOX-B is active and safe. Early parameters of efficacy are encouraging and seem similar to those observed with CRT. [Table: see text]

Preliminary results of surgical treatment and neoadjuvant chemotherapy in upper rectal cancer

“…Различный ответ на ХТ в указанных исследованиях можно объяснить проведением разных режимов ХТ (например, с добавлением таргетных препаратов) и различными временными промежутками между окончанием ХТ и операцией. Полный курс НАХТ в нашем исследовании окончили 91,5 % пациентов, что сопоставимо с другими исследованиями, в которых данный показатель составил от 73 % до 91 % [24][25][26][27].…”

The 2017 Assisi Think Tank Meeting on rectal cancer: A positioning paper

“…pCR rates ranged from 7% to 35%. Since patient cohorts were small and the studies were non-randomised, with short follow-ups, they were unable to show any impact on metastatic disease or local recurrence [61][62][63][64]. However, the proof of principle encouraged many current studies to explore neoadjuvant chemotherapy.…”

Neoadjuvant chemotherapy in the treatment of rectal cancer without mesorectal fascia involvement but with negative prognostic factors

“…Одним из основных вопросов является частота ответа на НАХТ и наличие дополнительных рисков для пациентов, резистентных к такому лечению. В многоцентровом исследовании II фазы GEMCAD 0801 Trial, где проводилась неоадъювантная ПХТ по схеме СарОх, объективный ответ опухоли отмечен в 78,6 % случаев [23]. В исследовании D. Schrag и соавт.…”

“…[29] сообщили о снижении критерия Т в 29, 63 и 50 % случаев опухолей T2-3, T4a и T4b соответственно. Частота регресса опухолевого поражения лимфатических узлов (cN + до ypN0) варьировала от 65 % [23,27,28] до 83,3 % [25,29].…”