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Phase II study of sunitinib as second-line treatment for advanced gastric cancer
Bang, Yung-Jue,Kang, Yoon-Koo,Kang, Won K.,Boku, Narikazu,Chung, Hyun C.,Chen, Jen-Shi,Doi, Toshihiko,Sun, Yan,Shen, Lin,Qin, Shukui,Ng, Wai-Tong,Tursi, Jennifer M.,Lechuga, Maria J.,Lu, Dongrui Ray,R Springer US 2011 Investigational new drugs Vol.29 No.6
<P><B>Summary</B></P><P><I>Purpose.</I> This phase II, open-label, multicenter study assessed the oral, multitargeted, tyrosine kinase inhibitor sunitinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma who had received prior chemotherapy. <I>Experimental design</I>. Patients received sunitinib 50 mg/day on Schedule 4/2 (4 weeks on treatment, followed by 2 weeks off treatment). The primary endpoint was objective response rate; secondary endpoints included clinical benefit rate, duration of response, progression-free survival (PFS), overall survival (OS), pharmacokinetics, pharmacodynamics, safety and tolerability, and quality of life. <I>Results</I>. Of 78 patients enrolled, most had gastric adenocarcinoma (93.6%) and metastatic disease (93.6%). All were evaluable for safety and efficacy. Two patients (2.6%) had partial responses and 25 patients (32.1%) had a best response of stable disease for ≥6 weeks. Median PFS was 2.3 months (95% confidence interval [CI], 1.6–2.6 months) and median OS was 6.8 months (95% CI, 4.4–9.6 months). Grade ≥3 thrombocytopenia and neutropenia were reported in 34.6% and 29.4% of patients, respectively, and the most common non-hematologic adverse events were fatigue, anorexia, nausea, diarrhea, and stomatitis. Pharmacokinetics of sunitinib and its active metabolite were consistent with previous reports. There were no marked associations between baseline soluble protein levels, or changes from baseline, and measures of clinical outcome. <I>Conclusions</I>. The progression-delaying effect and manageable toxicity observed with sunitinib in this study suggest that although single-agent sunitinib has insufficient clinical value as second-line treatment for advanced gastric cancer, its role in combination with chemotherapy merits further study.</P>
Fujitani, K.,Yang, H.-K.,Kurokawa, Y.,Park, D. J.,Tsujinaka, T.,Park, B.-J.,Fukuda, H.,Noh, S. H.,Boku, N.,Bang, Y.-J.,Sasako, M.,Lee, J.-I. Oxford University Press 2008 Japanese journal of clinical oncology Vol.38 No.7
<P>A randomized controlled trial has started in both Japan and Korea to evaluate the role of gastrectomy in the management of incurable advanced gastric cancer (AGC). Patients with AGC diagnosed as having a single non-curable factor are randomized to gastrectomy plus chemotherapy or chemotherapy alone. Surgeons at 33 specialized centers in Japan and at 15 high-volume hospitals in Korea will recruit 330 patients. Primary end-point is overall survival, and secondary end-points are progression-free survival and adverse events associated with either gastrectomy or chemotherapy.</P>
Sasaki, Yusuke,Hamaguchi, Tetsuya,Yamada, Yasuhide,Takahashi, Naoki,Shoji, Hirokazu,Honma, Yoshitaka,Iwasa, Satoru,Okita, Natsuko,Takashima, Atsuo,Kato, Ken,Nagai, Yushi,Taniguchi, Hirokazu,Boku, Nari Asian Pacific Journal of Cancer Prevention 2016 Asian Pacific journal of cancer prevention Vol.17 No.2
Background: It is well known that peritoneal carcinomatosis (PC) from colorectal cancer (CRC) is associated with a poor prognosis. However, data on the prognostic significance of modern chemotherapy containing bevacizumab, cetuximab or panitumumab are not available. Materials and Methods: This retrospective review concerned 526 patients with metastatic CRC who were classified into two groups according to the presence or absence of PC, and were treated with systemic chemotherapy, with or without bevacizumab or anti-EGFR antibodies. The genetic background, in particular KRAS, BRAF, and PIK3CA gene mutations, and overall survival (OS) were compared between the two groups. Results: The median OS values were 23.3 and 29.1 months for PC and non-PC patients, respectively (hazard ratio [HR]=1.20; p=0.17). Among all patients, tumor location, number of metastatic sites and BRAF mutation status were significant prognostic factors, whereas the presence of PC was not. In the PC group, chemotherapy with bevacizumab resulted in a significantly longer OS than forchemotherapy without bevacizumab (HR=0.38, p<0.01), but this was not the case in the non-PC group (HR=0.80, p=0.10). Furthermore, the incidence of the BRAF V600E mutation was significantly higher in PC than in non-PC patients (27.7% versus 7.3%, p<0.01). BRAF mutations displayed a strong correlation with shorter OS in non-PC (HR=2.26), but not PC patients (HR=1.04). Conclusions: Systemic chemotherapy, especially when combined with bevacizumab, improved survival in patients with PC from CRC as well as non-PC patients. While BRAF mutation demonstrated a high frequency in PC patients, but it was not associated with prognosis.