MA07.01 Updated Pooled Analysis of CNS Endpoints in Two Phase II Studies of Alectinib in ALK+ NSCLC

4109 Background: Retrospective data in some cancer types suggested a possible different toxicity profile with chemotherapy and targeted therapies according to gender. However, data from prospective studies are still very limited, especially in infrequent tumors such as NETs. Methods: Pts with advanced pancreatic and gastrointestinal NETs treated with pazopanib or lenvatinib in the multicenter open-label phase II studies PAZONET and TALENT respectively, were included in the analysis. Both studies were performed by Spanish Task Force Group for Neuroendocrine Tumors (GETNE). All toxicity grades with an incidence higher than 5% were considered for univariate review. Additionally, all grade 3-4 toxicities were analyzed separately. Results: 155 pts (47.7% female) with 1213 adverse events (AEs) (20% G3-4) divided in 121 categories were included. In female patients, liver toxicity, headache, pyrexia, nausea/vomiting, hair/skin disorders and dizziness were significantly more common (table). The only toxicity with higher incidence in men was dysphonia (OR 0.42, 95% CI 0.2-0.9, p 0.02). There were no gender differences in grade 3-4 toxicities. Conclusions: We observed significant differences in toxicity AEs by gender in two prospective phase II studies with MKIs in NETs patients. Potential different approach to manage toxicity may be adopted based on gender. [Table: see text]

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3113 AZD9291 in pre-treated patients with T790M positive advanced non-small cell lung cancer (NSCLC): Pooled analysis from two Phase II studies

European Journal of Cancer ◽

10.1016/s0959-8049(16)31754-3 ◽

2015 ◽

Vol 51 ◽

pp. S640 ◽

Cited By ~ 4

Author(s):

G.D. Goss ◽

J.C.H. Yang ◽

M.J. Ahn ◽

C.M. Tsai ◽

L. Bazhenova ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Phase Ii ◽

Cell Lung Cancer ◽

Pooled Analysis ◽

Small Cell ◽

Small Cell Lung ◽

Two Phase ◽

Phase Ii Studies

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Effectiveness and tolerability of ezetimibe in patients with primary hypercholesterolemia: pooled analysis of two phase II studies

Clinical Therapeutics ◽

10.1016/s0149-2918(01)80131-4 ◽

2001 ◽

Vol 23 (9) ◽

pp. 1601 ◽

Cited By ~ 3

Author(s):

H.E. Bays

Keyword(s):

Phase Ii ◽

Pooled Analysis ◽

Two Phase ◽

Primary Hypercholesterolemia ◽

Phase Ii Studies

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Three-year outcomes of two phase II studies of adjuvant chemotherapy with S-1 plus oxaliplatin or capecitabine plus oxaliplatin in patients with stage III gastric cancer after D2 gastrectomy.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.4_suppl.94 ◽

2018 ◽

Vol 36 (4_suppl) ◽

pp. 94-94 ◽

Cited By ~ 1

Author(s):

Yoshiaki Nakamura ◽

Takeharu Yamanaka ◽

Keisho Chin ◽

Haruhiko Cho ◽

Hitoshi Katai ◽

...

Keyword(s):

Gastric Cancer ◽

Adjuvant Chemotherapy ◽

Phase Ii ◽

Pooled Analysis ◽

Stage Iii ◽

Phase Ii Trials ◽

Two Phase ◽

D2 Gastrectomy ◽

Phase Ii Studies

94 Background: Two phase II trials of oxaliplatin-based adjuvant chemotherapy for patients (pts) with gastric cancer (GC) after D2 gastrectomy have been conducted in Japan; the J-CLASSIC study of capecitabine plus oxaliplatin (CAPOX) and the SOXaGC study of S-1 plus oxaliplatin (SOX). In the current study, we evaluated survival outcomes of the two trials. Methods: The J-CLASSIC, enrolling stage II and III pts from 12 centers between July 2012 and July 2013, evaluated eight cycles of CAPOX. The SOXaGC, enrolling stage III pts from 11 centers between July 2013 and February 2014, evaluated seven cycles of SOX after one cycle of S-1 monotherapy. The two studies were conducted sequentially and most centers (9 centers) participated in both trials. In this pooled analysis, we updated relapse-free survival (RFS) and overall survival (OS) information. The median follow-up time was 49 months in the J-CLASSIC and 39 months in the SOXaGC. Results: Fifty-nine stage III pts treated with CAPOX and 62 stage III pts treated with SOX were analyzed. The 3-year RFS and OS rates of SOX were 70.9% (57.8-80.5%) and 75.7% (63.0-84.6%), respectively, whereas the 3-year RFS and OS rates of CAPOX were 67.8% (54.3-78.1%) and 79.3% (66.5-87.7%), respectively. The hazard ratio (HR) of SOX in comparison to CAPOX was 0.925 (0.498-1.720) for RFS, suggesting the efficacy of the two treatments was similar. Trend of a different efficacy was observed in some particular subgroups; the HR for RFS was 1.732 (0.506-5.927) in the intestinal type and 0.735 (0.353-1.528) in the diffuse type, while that was 2.008 (0.447-9.016) in stage IIIA, 0.872 (0.266-2.857) in stage IIIB, and 0.597 (0.258-1.383) in stage IIIC. Conclusions: This is the first report of survival follow-up in Japanese GC pts with oxaliplatin-based adjuvant chemotherapy, which suggests comparable outcomes in both treatments for stage III GC. Different trend in the treatment effect by histologic type or stage warrants further evaluation in a larger cohort. Clinical trial information: UMIN000026883.

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