Pooled analysis of 121 patients from two phase II trials in NSCLC and mesothelioma show the safety of Tumor Treating Fields applied to the thorax

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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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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A pooled analysis of two phase II trials evaluating metformin plus platinum-based chemotherapy in advanced non-small cell lung cancer

Cancer Treatment and Research Communications ◽

10.1016/j.ctarc.2019.100150 ◽

2019 ◽

Vol 20 ◽

pp. 100150 ◽

Cited By ~ 3

Author(s):

Anish B. Parikh ◽

Kristen A. Marrone ◽

Daniel J. Becker ◽

Julie R. Brahmer ◽

David S. Ettinger ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Phase Ii ◽

Cell Lung Cancer ◽

Pooled Analysis ◽

Small Cell ◽

Small Cell Lung ◽

Phase Ii Trials ◽

Two Phase ◽

Platinum Based Chemotherapy

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Exploring new potentials and generating hypothesis for management of locally advanced head neck cancer: Analysis of pooled data from two phase II trials

Journal of Cancer Research and Therapeutics ◽

10.4103/0973-1482.65239 ◽

2010 ◽

Vol 6 (2) ◽

pp. 185 ◽

Cited By ~ 2

Author(s):

KundanS Chufal ◽

Madhup Rastogi ◽

Sudhir Singh ◽

MC Pant ◽

Madhu Srivastava ◽

...

Keyword(s):

Phase Ii ◽

Neck Cancer ◽

Locally Advanced ◽

Head Neck Cancer ◽

Advanced Head ◽

Phase Ii Trials ◽

Two Phase ◽

Pooled Data ◽

Head Neck ◽

Generating Hypothesis

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Responses to second-line cisplatin-based intraperitoneal therapy in ovarian cancer: influence of a prior response to intravenous cisplatin.

Journal of Clinical Oncology ◽

10.1200/jco.1991.9.10.1801 ◽

1991 ◽

Vol 9 (10) ◽

pp. 1801-1805 ◽

Cited By ~ 140

Author(s):

M Markman ◽

B Reichman ◽

T Hakes ◽

W Jones ◽

J L Lewis ◽

...

Keyword(s):

Ovarian Cancer ◽

Phase Ii ◽

Small Volume ◽

Recurrent Ovarian Cancer ◽

Second Line ◽

Front Line ◽

Phase Ii Trials ◽

Two Phase ◽

Overall Response ◽

Intraperitoneal Therapy

Phase II trials of second-line intraperitoneal (IP) cisplatin-based therapy in patients with ovarian cancer have demonstrated the ability of this approach to produce objective antitumor responses, including surgically defined complete responses (CRs), in individuals with persistent small-volume disease after front-line cisplatin-based intravenous (IV) treatment. To examine the influence of a prior response to systemic cisplatin on the activity of second-line IP cisplatin, we retrospectively analyzed two phase II trials of cisplatin-based IP therapy in persistent/recurrent ovarian cancer conducted at our institution. Of the 89 assessable patients on the two trials, 52 (58%) had previously responded to IV cisplatin. The overall response and CR rates to second-line IP cisplatin-based therapy in this previously responding population were 56% and 33%, respectively, compared with overall response and CR rates in the 37 nonresponders to IV cisplatin of 11% and 3%, respectively (P less than .001; chi 2, 1 df). In the 36 patients responding to systemic cisplatin and whose largest tumor mass measured less than 1 cm at IP cisplatin initiation, a 42% CR rate was observed, compared with a 7% CR rate in the 14 patients with the same bulk of disease who had previously failed to respond to systemic cisplatin (P less than .025). We conclude that a prior response to systemic cisplatin strongly influences the antineoplastic activity of second-line IP cisplatin in ovarian cancer.

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