Randomized Phase III Trial Comparing Weekly Docetaxel Plus Cisplatin Versus Docetaxel Monotherapy Every 3 Weeks in Elderly Patients With Advanced Non–Small-Cell Lung Cancer: The Intergroup Trial JCOG0803/WJOG4307L

Abe, Tetsuya; Takeda, Koji; Ohe, Yuichiro; Kudoh, Shinzoh; Ichinose, Yukito; Okamoto, Hiroaki; Yamamoto, Nobuyuki; Yoshioka, Hiroshige; Minato, Koichi; Sawa, Toshiyuki; Iwamoto, Yasuo; Sasaki, Hideo; Mizusawa, Junki; Shibata, Taro; Nakamura, Shinichiro; Ando, Masahiko; Yokoyama, Akira; Nakagawa, Kazuhiko; Saijo, Nagahiro; Tamura, Tomohide

doi:10.1200/jco.2014.55.8627

Cited by 103 publications

(83 citation statements)

References 21 publications

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“…Single agents, including docetaxel or vinorelbine, have been recommended for the treatment of elderly patients with advanced NSCLC. In Japan, the results of phase III trials reported by Kudoh et al (22) and Abe et al (5) indicated that docetaxel was suitable for such patients. Kudoh et al (22) reported the OS, PFS and ORR of docetaxel were 14.3 months, 5.5 months and 22.7%, respectively.…”

Section: Responsementioning

confidence: 99%

“…The incidence of lung cancer has been increasing among elderly individuals, and single agents including vinorelbine and docetaxel have been widely used as first-line treatments against NSCLC in elderly patients with advanced disease in Japan. In a phase III study, Abe et al (5) reported that the survival time following docetaxel monotherapy was significantly increased compared with combination therapy with docetaxel plus cisplatin in elderly patients with advanced NSCLC. Therefore, it remains unclear whether combination chemotherapy improves survival compared with monotherapy in these patients.…”

Section: Introductionmentioning

confidence: 99%

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Prospective exploratory study of gemcitabine and S-1 against elderly patients with advanced non-small cell lung cancer

et al. 2017

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Abstract.A prospective study was conducted to investigate the efficacy of a combined regimen of gemcitabine and S-1 for the treatment of elderly patients (>70 years) with advanced non-small cell lung cancer (NSCLC) as a first-line setting based on the dosage recommended in a previous phase I study. Chemotherapy-naïve patients with advanced NSCLC received gemcitabine plus S-1. S-1 (40 mg/m 2 ) was administered orally twice daily for 14 days while gemcitabine (1,000 mg/m 2 ) was administered on days 1 and 15 of each cycle, and this regimen was repeated every 4 weeks. A total of 20 patients were included in the present study. Of these, 8 patients achieved an overall response rate of 40.0%, and the overall disease control rate was 65.0%. According to the histological type, the response rate in patients with NSCLC and adenocarcinoma was 38.5%, and that for non-adenocarcinoma was 42.9%. Progression-free survival and median survival times were 6.4 months and 17.8 months, respectively. Grade 3 or 4 hematological toxicities observed were leukopenia (29%) and neutropenia (24%), while febrile neutropenia was not observed in any patient. The only non-hematological adverse event observed was grade 3 skin rash (10%). Therefore, the combination of gemcitabine and S-1 may be a promising and feasible regimen in the first-line setting for elderly patients with advanced NSCLC.

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Section: Responsementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Prospective exploratory study of gemcitabine and S-1 against elderly patients with advanced non-small cell lung cancer

et al. 2017

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“…Currently, no positive trial of platinum doublets chemotherapy has been verified for elderly Japanese patients with advanced NSCLC, as was recently demonstrated by the Japanese cohort (JCOG0803/ WJOG4307L trial) study which was terminated earlier than planned in the interim analysis [12]. Thus, the standard of care for such patients remains as docetaxel singlet chemotherapy at a dose of 60 mg/m 2 , which is based on the recommended dose for a Japanese cohort [13].…”

Section: Discussionmentioning

confidence: 93%

A phase II study of nanoparticle albumin-bound paclitaxel plus carboplatin as the first-line therapy in elderly patients with previously untreated advanced non-small cell lung cancer

Okuma

Hosomi

Takahashi

et al. 2016

Cancer Chemother Pharmacol

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“…Both combinations demonstrated to be safe. Better results in terms of ORR and MST were demonstrated by Ohe et al [42] in patients aged ≥ 75 years by adding docetaxel to weekly cisplatin [42,43] . In 2007 Gridelli et al [44] tested in the MILES 2P the feasibility of cisplatin with gemcitabine or vinorelbine in elderly patients.…”

Section: Platinum-based Chemotherapy: Prospectives Studiesmentioning

confidence: 95%

Advanced non-small cell lung cancer in elderly patients: A review

Buffoni¹

2015

WJR

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Over 50% of patients diagnosed with non-smallcell lung cancer (NSCLC) are 65 years old while 30% exceed 70 years old. Comparing elderly patients to their younger counterpart they poorly tolerate chemotherapy due to progressive reduction of organ function and age-related co-existing pathologies. Due to this reason elderly are usually excluded from platinum-based chemotherapy, which still represent the standard of care for advanced NSCLC. In every-day practice, single-agent schedule with a third-generation drug is the recommended option for elderly patients with advanced NSCLC. A modest increase in toxicity for elderly patients has been demonstrated by subgroup analyses concluding for platinum-based combination chemotherapy being similar in young patients and fit elderly. Even though the cited evidence, feasibility of chemotherapy based on platinum remains an open question. Prospective randomised trials are warranted in order to change guide lines and give the clinicians a new therapeutic option. Recent emerging role of molecular target in selecting patients for new targeted therapies suggest dedicated trials for elderly patients. The same is for more accurate evaluation of elderly patients with increasing evidence for a comprehensive geriatric assessment as a valid tool for customized treatment in NSCLC elderly patients. Suitable evidences for the treatment of elderly patients affected by advanced NSCLC together with more appropriate and validated tools for patients selection are reviewed along the manuscript.

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Randomized Phase III Trial Comparing Weekly Docetaxel Plus Cisplatin Versus Docetaxel Monotherapy Every 3 Weeks in Elderly Patients With Advanced Non–Small-Cell Lung Cancer: The Intergroup Trial JCOG0803/WJOG4307L

Abstract: This study failed to demonstrate any survival advantage of weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for advanced NSCLC in elderly patients.

Cited by 103 publications

References 21 publications

Prospective exploratory study of gemcitabine and S-1 against elderly patients with advanced non-small cell lung cancer

Prospective exploratory study of gemcitabine and S-1 against elderly patients with advanced non-small cell lung cancer

A phase II study of nanoparticle albumin-bound paclitaxel plus carboplatin as the first-line therapy in elderly patients with previously untreated advanced non-small cell lung cancer

Advanced non-small cell lung cancer in elderly patients: A review

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