Long-term results of a multicenter phase II study of preoperative chemoradiotherapy with S-1 plus oxaliplatin for locally advanced rectal cancer (JACCRO CC-04: SHOGUN Trial)
| Autor: | Soichiro Ishihara, Satoshi Matsusaka, Hideomi Yamashita, Keisaku Kondo, Kazushige Kawai, Masashi Fujii, Masashi Ueno, Yojiro Hashiguchi, Toshifusa Nakajima, T. Shimbo, Yuichi Ishikawa, Masahiko Oguchi, Nobuyuki Mizunuma, Eiji Sunami, Daiki Kato, Keisuke Uehara, Keiko Murafushi, Masanori Nakazawa, Hisanaga Horie, Tohru Okada, Junji Okuda |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Colorectal cancer medicine.medical_treatment Phases of clinical research Gastroenterology Disease-Free Survival 030218 nuclear medicine & medical imaging Metastasis 03 medical and health sciences 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols Preoperative Care medicine Clinical endpoint Humans Radiology Nuclear Medicine and imaging Aged Neoplasm Staging Tegafur Rectal Neoplasms business.industry Standard treatment Chemoradiotherapy Hematology Middle Aged Esophageal cancer medicine.disease Neoadjuvant Therapy Oxaliplatin Radiation therapy Drug Combinations Oxonic Acid Oncology 030220 oncology & carcinogenesis Female business medicine.drug |
| Zdroj: | Radiotherapy and Oncology. 134:199-203 |
| ISSN: | 0167-8140 |
| Popis: | Purpose The study was designed to evaluate the safety and efficacy of adding oxaliplatin to py (CRT) with S-1 in patients with locally advanced rectal carcinoma (LARC). We report here the final results of the study. Patients and methods Patients with histopathologically confirmed LARC (cT3-T4, any N) were eligible. They received oral S-1 (80 mg/m2/day on days 1–5, 8–12, 22–26, and 29–33) and infusional oxaliplatin (60 mg/m2/day on days 1, 8, 22, 29) plus radiotherapy (1.8 Gy/day, total dose of 50.4 Gy in 28 fractions), with a chemotherapy gap in the third week of radiotherapy. Primary endpoint of the study was pathological complete response (pCR) rate. Secondary endpoints were rates of R0 resection, down-staging, cumulative 3-year local recurrence, 3-year disease-free survival (DFS), and toxicity. Results Forty-five patients were enrolled at six centers in Japan. All patients received CRT, and 44 underwent operation. The pCR rate was 27.3% (12/44). The R0 resection rate was 95.5% (42/44). T-down-staging rate was 59.1% (26/44), and N-down staging rate was 65.9% (29/44); the combined pathological down-staging rate was 79.5% (35/44). There were no grade 4 adverse events, but 11.1% of the patients had grade 3 adverse events. Cumulative 3-year local recurrence rate was 0%. However, 13 (30.0%) patients suffered from distant metastasis, and one patient suffered from secondary esophageal cancer that was unrelated to rectal cancer. Eight patients had lung metastasis, 4 had liver metastasis, and 3 patients died of the metastatic disease. The 3-year DFS rate of the 44 patients was 67.5% (median follow-up 36.3 months), and the 3-year overall survival (OS) rate was 93.0% (median follow-up 39.6 months). The patients were then divided into the pCR (12 patients) group and non pCR (32 patients) group. The 3-year rate of DFS for each group was 91.7% and 58.1% and that of OS was 100% and 90.3%, respectively. Conclusions The study showed a high pCR rate with no severe toxicity, good follow-up results, and good loco-regional control. Therefore, addition of oxaliplatin to preoperative CRT with S-1 in patients with LARC might be feasible and lead to better local control than standard treatment. |
| Databáze: | OpenAIRE |
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