A Phase I/II Study of Concurrent S-1 and Intensity Modulated Radiotherapy as Adj
PUBLISHED: 2015-11-27  415 total views, 1 today

Xin Wang1, Hua Ren2, Jing Jin2, Yuan Tang2, Hui Fang2, Ning Li2Yong-wen Song2, Xue-song Chen2, Tao Zhang2, Wei-hu Wang2, Shu-lian Wang2Yue-ping Liu2, Zi-hao Yu2, Xin-fan Liu2, Ye-xiong Li2

1Department of Radiation Oncology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking union   Medical College (PUMC), 2Chinese Academy of Medical Sciences (CAMS) and Peking union   Medical College (PUMC), Cancer Hospital and Institute

Objective:This phase I/II trial aimed to determine the maximum tolerated dose (MTD) and toxicity profile of S-1 with concomitant intensity modulated radiotherapy (IMRT) as an adjuvant treatment for locally advanced gastroesophageal and gastric cancer. Method: We consecutively enrolled patients with pathologically proved locally advanced gastroesophageal or gastric adenocarcinoma (T3-4N0M0 or anyTN+M0) after complete resection with negative margins (R0). IMRT was delivered of 45 Gy (1.8 Gy/fraction, 5 days/week). S-1 was administered every weekday at a dosage (mg/m2/d) of 30 (level I, n=6), 40 (level II, n=3), 50 (level III, n=6), 60 (level IV, n=3), 70 (level V, n=3), 80 (level VI, n=6). A phase II study was conducted with the recommended dose (RD) based on phase I. An experienced physicist designed the IMRT plans using a five-to-seven-field, coplanar, sliding window technique on the Pinnacle system, version 8.0-9.0. This trial was registered with ClinicalTrials.gov, number NCT 02296658. Result: From May 2010 to December 2014, 61 patients were consecutively recruited (6 with stage II, 55 with stage III, AJCC 7th). The MTD and RD of S-1 was 80mg/m2/d administered every weekday. Dose-limiting toxicities were Grade 3 nausea, anorexia and thrombocytopenia. In the phase II study, thirty seven patients (92.5%) completed radiotherapy and thirty one (77.5) completed concomitant chemotherapy. Grade 3-4 toxicities were: nausea/anorexia (5 patients, 12.5%), leukopenia (4 patients, 10.0%), vomiting (3 patients, 7.5%), esophagitis (2 patients, 5%) and neutropenia (2 patients, 5%). No patients occurred liver or kidney dysfunction or died within the 30 days after chemoradiotherapy. With a median follow-up of 20 months (range 1.5-57.7), 2-year overall survival (OS), disease-free survival (DFS), locoregional-free survival (LRFS) and distant-metastasis free survival (DMFS) were 77.6%, 65.8%, 92.8% and 73.6%, respectively. Among 61 patients, 13 patients died of disease recurrence. 15 patients developed 13 items of distant metastasis and 4 items of locoregional relapse. Conclusion: S-1 with concurrent IMRT was feasible and tolerable for locally advanced gastroesophageal and gastric cancer patients as an adjuvant setting. The MTD and RD of S-1 was 80mg/m2/d administered every weekday. Distant metastasis was the most common failure mode.


Key Words: Gastric cancer  Chemoradiotherapy  S-1

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