A Prospective Phase I/II Study of Docetaxel, Cisplatin and Continuous Capecitabine in Advanced Oesophago-Gastric Cancer (NWCOG-3). Issue 7 (July 2018)

• Record Type: Journal Article
• Authors: Gollins, S.; Massalha, S.; Mullard, A.; Williams, R.M.; Lloyd, A.; Morris, J.; Garcia-Alonso, A.
• Is Part Of: Clinical oncology. Volume 30:Issue 7(2018)
• Page Start: 409
• Page End: 417
• Publication Date: 2018-07
• Subjects: Advanced oesophago-gastric cancer -- chemotherapy -- cisplatin and capecitabine -- docetaxel -- phase I/II trial; Oncology -- Periodicals; Tumors -- Periodicals; Cancer -- Treatment -- Periodicals; Radiotherapy -- Periodicals; Neoplasms -- Periodicals; Cancer -- Radiotherapy; Cancer -- Treatment; Oncology; Medical radiology; Radiotherapy; Tumors; Electronic journals; Periodicals; 616.994
• DOI: 10.1016/j.clon.2018.03.002
• Languages: English
• ISSNs: 0936-6555

Abstract

Abstract: Aims: This open-label prospective phase I/II dose-escalation study determined the maximum tolerated dose (MTD) and then evaluated response, safety and feasibility of a novel combination of docetaxel, cisplatinum and capecitabine (DCC) in chemotherapy-naive patients with advanced oesophago-gastric carcinoma. Materials and methods: Patients with adenocarcinoma or squamous cell carcinoma of the oesophagus or stomach, of good performance status, deemed too advanced for curative treatment, were given systematically increasing doses of 3 weekly DCC to ascertain the MTD. Phase II administered up to six cycles of DCC at the MTD, assessing response and toxicity. Results: Between November 2007 and November 2012, 15 patients were recruited into phase I and 41 into phase II. The MDT was a 21 day cycle of docetaxel 60 mg/m 2 IV day 1, cisplatinum 60 mg/m 2 IV day 1 and oral capecitabine 1000 mg/m 2 daily in two divided doses for days 1–21. The most common phase II grade 3–4 toxicities were neutropenia 88% (10% febrile neutropenia), fatigue 15%, sensory neuropathy 10% and non-neutropenic infection 10%. The overall response rate was 51%, median progression-free survival was 7.4 months (confidence interval 6.7–9.4) and median overall survival was 10.9 months (confidence interval 7.7–13.7). Conclusion: DCC was tolerable and feasible with promising efficacy, and may be suitable for future investigation in both first-line metastatic and neoadjuvant settings. Highlights: DCC is tolerable and feasible with promising efficacy in oesophago-gastric cancer. MTD docetaxel 60 mg/m 2, cisplatinum 60 mg/m 2, oral capecitabine 1000 mg/m 2 (DCC). Most common phase II toxicities: neutropenia 88% (10% febrile neutropenia), fatigue 15%. Overall response rate of DCC 51%, median overall survival 10.9 months (CI 7.7–13.7).