Monotherapy with S-1 demonstrated noninferiority to gemcitabine in overall survival with good tolerability and presents a convenient oral alternative for locally advanced and metastatic pancreatic cancer.
The aims of this phase I/II study of docetaxel and S-1 were to determine the dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), and recommended dose (RD) in the phase I part and to explore the tumour response, survival and safety in the phase II part. Patients with histologically-or cytologically confirmed unresectable or recurrent gastric cancer were eligible. Treatment consisted of intravenous docetaxel on day 1 (starting dose 50 mg m À2 ) and oral S-1 at a fixed dose of 40 mg m À2 twice daily on days 1 -14, every 4 weeks up to six cycles. Nine patients took part in the phase I portion of the study. The MTD of docetaxel was determined to be 50 mg m À2 , with the DLTs of grade 3 infection associated with grade 3 neutropenia and grade 4 neutropenia during S-1 administration. The RD of docetaxel was 40 mg m À2 in combination with S-1 40 mg m À2 b.i.d. The efficacy and safety of this regimen was therefore assessed in 46 patients with at least one measurable lesion. The overall response rate and estimated median overall survival were 46% (95% CI, 31 -61%) and 14.0 months (8.3 -17.3 months), respectively. The most common grade 3/4 toxicity was neutropenia (67% of patients), which was predictable and manageable. This regimen showed promising activity with moderate toxicities in advanced gastric cancer.
Advances in techniques of image diagnosis have enabled the detection of minute or small cancer lesions in the stomach. Patients with such cancer, in principle, were treated surgically, but accumulated histopathological data on surgical cancer specimens revealed that many of these patients did not have any metastatic lesions. For those localized cancers, local treatment of primary lesions by endoscopy gives curative results. It has been demonstrated that endoscopic therapy is curative in mucosal well-differentiated adenocarcinoma not more than 20 mm in diameter without ulceration. Efforts to cure early gastric cancer without surgery yielded fruitful results and a new treatment concept was established. Even if there is a recurrence of the residual or metachronous lesions, they can be treated by further endoscopic treatment.
Adjuvant chemotherapy with S-1 is feasible treatment in patients with resected biliary tract cancer. It is necessary to conduct a phase III study to confirm the efficacy of adjuvant therapy of S-1 in patients with resected BTC.
Cediranib (20 or 30 mg) in combination with mFOLFOX6 was considered tolerable according to the protocol-defined criteria, providing justification for the Phase II part of this study.
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