Cancer Chemother Pharmacol (2015) 76:731–737 DOI 10.1007/s00280-015-2839-z
ORIGINAL ARTICLE
Phase II study of first‑line biweekly docetaxel and cisplatin combination chemotherapy in advanced gastric cancer G. Quintero‑Aldana1 · M. Jorge2 · C. Grande2 · M. Salgado3 · E. Gallardo4 · S. Varela1 · C. López2 · M. J. Villanueva2 · A. Fernández3 · E. Alvarez1 · P. González2 · J. Castellanos2 · J. Casal2 · R. López4 · B. Campos Balea1
Received: 19 May 2015 / Accepted: 27 July 2015 / Published online: 5 August 2015 © Springer-Verlag Berlin Heidelberg 2015
Abstract Purpose Previous studies have shown that docetaxel and cisplatin, as single agents, are effective and relatively well tolerated in patients with advanced gastric cancer. The aim of this study was to assess efficacy and toxicity of a biweekly regimen of docetaxel plus cisplatin in patients with advanced gastric cancer. Patients/methods Fifty-five patients with histologically proven advanced gastric cancer with at least 1 measurable lesion and ECOG PS ≤ 2 were enrolled. Patients received docetaxel 50 mg/m2 and cisplatin 50 mg/m2 every 2 weeks until progression disease, unbearable toxicity or a maximum of 12 cycles. Results In total, 426 cycles were administered (median 8.5 cycles) to 52 evaluable patients. One patient (1.9 %) showed a complete response, while 21 (40.4 %) had partial responses. The objective response rate was 42.3 % (95 % CI 28.9–55.7), the median time to progression was 5.5 months (95 % CI 4.0–7.0), and the median overall survival was 8.9 months (95 % CI 6.0–11.9). The most common grade 3–4 toxicities per cycle were haematological [neutropenia (5.9 %)]. Conclusions Biweekly administration of docetaxel and cisplatin in advanced gastric cancer has a manageable
* A. Fernández [email protected] 1
Hospital Universitario Lucus, Augusti, Lugo, Spain
2
Complejo Hospitalario Universitario de Vigo, CHUVI, Vigo, Spain
3
Complejo Hospitalario de Ourense, CHOU, Ourense, Spain
4
Complejo Hospitalario Universitario de Santiago, CHUS, Santiago de Compostela, Spain
toxicity profile and shows a promising antitumour activity as a first-line therapy. Keywords Advanced gastric cancer · Cisplatin · Combination chemotherapy · Docetaxel
Introduction Gastric cancer (GC) is the fourth most common cancer worldwide (7.8 % of cancers) and the second most frequent cancer-related cause of death (9.7 % of cancer deaths). Approximately half of new gastric cancer cases occur in East Asia [1]. In Western countries, 80–90 % of patients are usually either diagnosed at an advanced inoperable disease or develop recurrence within 5 years after surgery with curative intention [2]. Advanced gastric cancer patients have a poor prognosis with a median survival time, for those untreated, of 3–5 months. The 5-year survival for advanced/ metastatic gastric cancer is
ORIGINAL ARTICLE
Phase II study of first‑line biweekly docetaxel and cisplatin combination chemotherapy in advanced gastric cancer G. Quintero‑Aldana1 · M. Jorge2 · C. Grande2 · M. Salgado3 · E. Gallardo4 · S. Varela1 · C. López2 · M. J. Villanueva2 · A. Fernández3 · E. Alvarez1 · P. González2 · J. Castellanos2 · J. Casal2 · R. López4 · B. Campos Balea1
Received: 19 May 2015 / Accepted: 27 July 2015 / Published online: 5 August 2015 © Springer-Verlag Berlin Heidelberg 2015
Abstract Purpose Previous studies have shown that docetaxel and cisplatin, as single agents, are effective and relatively well tolerated in patients with advanced gastric cancer. The aim of this study was to assess efficacy and toxicity of a biweekly regimen of docetaxel plus cisplatin in patients with advanced gastric cancer. Patients/methods Fifty-five patients with histologically proven advanced gastric cancer with at least 1 measurable lesion and ECOG PS ≤ 2 were enrolled. Patients received docetaxel 50 mg/m2 and cisplatin 50 mg/m2 every 2 weeks until progression disease, unbearable toxicity or a maximum of 12 cycles. Results In total, 426 cycles were administered (median 8.5 cycles) to 52 evaluable patients. One patient (1.9 %) showed a complete response, while 21 (40.4 %) had partial responses. The objective response rate was 42.3 % (95 % CI 28.9–55.7), the median time to progression was 5.5 months (95 % CI 4.0–7.0), and the median overall survival was 8.9 months (95 % CI 6.0–11.9). The most common grade 3–4 toxicities per cycle were haematological [neutropenia (5.9 %)]. Conclusions Biweekly administration of docetaxel and cisplatin in advanced gastric cancer has a manageable
* A. Fernández [email protected] 1
Hospital Universitario Lucus, Augusti, Lugo, Spain
2
Complejo Hospitalario Universitario de Vigo, CHUVI, Vigo, Spain
3
Complejo Hospitalario de Ourense, CHOU, Ourense, Spain
4
Complejo Hospitalario Universitario de Santiago, CHUS, Santiago de Compostela, Spain
toxicity profile and shows a promising antitumour activity as a first-line therapy. Keywords Advanced gastric cancer · Cisplatin · Combination chemotherapy · Docetaxel
Introduction Gastric cancer (GC) is the fourth most common cancer worldwide (7.8 % of cancers) and the second most frequent cancer-related cause of death (9.7 % of cancer deaths). Approximately half of new gastric cancer cases occur in East Asia [1]. In Western countries, 80–90 % of patients are usually either diagnosed at an advanced inoperable disease or develop recurrence within 5 years after surgery with curative intention [2]. Advanced gastric cancer patients have a poor prognosis with a median survival time, for those untreated, of 3–5 months. The 5-year survival for advanced/ metastatic gastric cancer is
