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Maemondo M.,Miyagi Cancer Center | Inoue A.,Tohoku University | Kobayashi K.,International University of Japan | Sugawara S.,Sendai Kousei Hospital | And 19 more authors.
New England Journal of Medicine | Year: 2010

BACKGROUND: Non-small-cell lung cancer with sensitive mutations of the epidermal growth factor receptor (EGFR) is highly responsive to EGFR tyrosine kinase inhibitors such as gefitinib, but little is known about how its efficacy and safety profile compares with that of standard chemotherapy. METHODS: We randomly assigned 230 patients with metastatic, non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy to receive gefitinib or carboplatin-paclitaxel. The primary end point was progression-free survival; secondary end points included overall survival, response rate, and toxic effects. RESULTS: In the planned interim analysis of data for the first 200 patients, progression-free survival was significantly longer in the gefitinib group than in the standard-chemotherapy group (hazard ratio for death or disease progression with gefitinib, 0.36; P<0.001), resulting in early termination of the study. The gefitinib group had a significantly longer median progression-free survival (10.8 months, vs. 5.4 months in the chemotherapy group; hazard ratio, 0.30; 95% confidence interval, 0.22 to 0.41; P<0.001), as well as a higher response rate (73.7% vs. 30.7%, P<0.001). The median overall survival was 30.5 months in the gefitinib group and 23.6 months in the chemotherapy group (P = 0.31). The most common adverse events in the gefitinib group were rash (71.1%) and elevated amino transferase levels (55.3%), and in the chemotherapy group, neutropenia (77.0%), anemia (64.6%), appetite loss (56.6%), and sensory neuropathy (54.9%). One patient receiving gefitinib died from interstitial lung disease. CONCLUSIONS: First-line gefitinib for patients with advanced non-small-cell lung cancer who were selected on the basis of EGFR mutations improved progression-free survival, with acceptable toxicity, as compared with standard chemotherapy. (UMIN-CTR number, C000000376.) Copyright © 2010 Massachusetts Medical Society. Source


Sugiyama T.,Tochigi Cancer Center | Kasai T.,Tochigi Cancer Center | Kamiyama Y.,Tochigi Cancer Center | Mori K.,Tsuboi Cancer Center Hospital
Japanese Journal of Lung Cancer | Year: 2015

Objective. The aim of this study was to prove the antiemetic efficacy of aprepitant in patients treated with a combined regimen of pemetrexed and carboplatin. Methods. A phase II trial of a combined regimen of carboplatin (AUC 6) and pemetrexed (500 mg/m2) was conducted. The two drugs were administered on day 1 and every 3 weeks thereafter. Aprepitant was not administered during the first course but was given as an additional treatment from the second course to 14 patients who experienced grade ≥2 nausea in the first course, in order to investigate its antiemetic efficacy. Results. There were 11 male and 3 female patients, with a median age of 62 years. Four patients had a performance status (PS) of 0, and 10 had a PS of 1. All of the cases were of adenocarcinoma. During the first course, grade 2 and 3 nausea occurred in 12 and 2 patients; grade 0,1, and 2 vomiting, in 7, 6, and 1 patients; and grade 1, 2, and 3 anorexia, in 6, 6, and 2 patients, respectively. All of the cases corresponded to the delayed phase. During the second course, grade 0,1, and 2 nausea occurred in 8, 2, and 4 patients; grade 0 and 1 vomiting, in 13 and 1 patients; and grade 0, 1, and 2 anorexia, in 7, 3, and 4 patients, respectively; which indicated a significant improvement. The severity of nausea, vomiting and anorexia decreased in 11 (78.5%), 13 (92.8%); and 8 (57.1%) patients, respectively. Conclusion. Aprepitant was an effective antiemetic in patients who were treated with pemetrexed/carboplatin and could be useful in the delayed phase. © 2015 The Japan Lung Cancer Society. Source


Noro R.,Nippon Medical School | Yoshimura A.,Nippon Medical School | Yoshimura A.,Tokyo Medical University | Yamamoto K.,Nippon Medical School | And 13 more authors.
Anticancer Research | Year: 2013

Background: A phase II study was conducted in order to determine the tumor efficacy and tolerance of alternating chemotherapy for extensive-stage small cell lung cancer (ED-SCLC). Patients and Methods: Twenty patients with previously-untreated ED-SCLC were enrolled in the study. At least four courses of chemotherapy consisting of alternation of two drug combinations were given: alternating cycles of amrubicin and cisplatin with weekly administration of irinotecan and cisplatin at 3- or 4-week intervals. Results: The overall response rate was 85.0% (17/20). The median duration of overall survival and progression-free survival were 359 days and 227 days, respectively. Hematological toxicity was the main adverse event. Grade 3 or 4 neutropenia, thrombocytopenia and anemia were observed in 20 (100%), 4 (20%) and 6 (30%) patients, respectively. With regard to non-hematological adverse events, grade 3 or 4 anorexia, diarrhea, febrile neutropenia and infection were observed in 5 (25%), 2 (10%), 2 (10%) and 2 (10%) patients, respectively. No treatment-related death occurred during either regimen. Conclusion: The novel alternating non-cross-resistant chemotherapy was probably active against ED-SCLC and had acceptable toxicities. Further evaluation of this treatment for ED-SCLC in randomized phase III trials is warranted. Source


Ichinose Y.,National Kyushu Cancer Center | Seto T.,National Kyushu Cancer Center | Nishiwaki Y.,National Cancer Center Hospital East | Kiura K.,Okayama University | And 5 more authors.
Japanese Journal of Clinical Oncology | Year: 2011

Objective: A single-agent topotecan has an indication for the treatment of small cell lung cancer in Japan. Previous studies demonstrated that topotecan combined with a platinum agent could provide additional antitumor efficacy. This study was to find the recommended dose of topotecan in combination with cisplatin and preferred administration sequence in untreated patients with extensive disease small cell lung cancer for Phase II study. Methods: Patients received topotecan as a 30 min infusion for 5 days in escalating doses (starting at 0.5 mg/m2/day), and cisplatin at a fixed dose of 60 mg/m2, 3 weeks cycle. This study employed the following stages: cisplatin was given before topotecan on day 1 to previously treated patients (Stage 1). After the maximum-tolerated dose level was achieved, the same schedule was applied for untreated patients (Stage 2). Subsequently, cisplatin was given after topotecan on day 5 to untreated patients (Stage 3). The recommended doses of cisplatin on day 1 and 5 schedules were estimated by considering results obtained from Stages 2 and 3, respectively. Results: A total of 34 patients were enrolled. The maximum-tolerated doses in Stages 1-3 were estimated at 0.65, 0.65, and 1.4 mg/m2, respectively. The recommended doses of cisplatin on day 1 and 5 schedules in untreated patients were determined at 0.65 and 1.0 mg/m2, respectively. The major toxicity in this combination was hematological events. Conclusions: For treatment-naive patients, the combined use of 0.65/60 mg/m2 topotecan/cisplatin with cisplatin on day 1 schedule or 1.0/60 mg/m2 topotecan/cisplatin with cisplatin on day 5 schedule is recommended for Phase II study. © The Author (2010). Published by Oxford University Press. All rights reserved. Source


Yoshimura A.,Nippon Medical School | Yoshimura A.,Tokyo Medical University | Noro R.,Nippon Medical School | Miyanaga A.,Nippon Medical School | And 10 more authors.
Anticancer Research | Year: 2012

Background: A phase II study was conducted to determine the tumor efficacy and tolerance of alternating chemotherapy in extensive-stage small-cell lung cancer (ED-SCLC). Patients and Methods: Thirty-six patients with previously untreated ED-SCLC were enrolled in the study. At least four courses of chemotherapy consisting of alternation of two drug combinations were given: alternating cycles of etoposide and carboplatin (EC) with weekly administration of irinotecan and cisplatin (IP) at 3- or 4-week intervals. Results: The overall response rate was 81.8%. The median duration of survival and progression-free survival were 314 days and 144 days, respectively. Hematological toxicity was the main adverse event. Grade 3 or 4 neutropenia, thrombocytopenia and anemia were observed in 69.2, 25.6 and 23.1% of the patients, respectively. Severe diarrhea (10.8%) was remarkable during the IP regimen. Conclusion: This novel alternating chemotherapy for patients with ED-SCLC showed moderate tumor efficacy and an acceptable safety profile. Source

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