Phase II study of S-1 and docetaxel for previously treated patients with locally advanced or metastatic non-small cell lung cancer

Yanagihara, Kazuhiro; Yoshimura, Kenichi; Niimi, Miyuki; Yasuda, Hiroyasu; Sasaki, Takuma; Nishimura, Takafumi; Ishiguro, Hiroshi; Matsumoto, Shigemi; Kitano, Toshiyuki; Kanai, Masashi; Misawa, Akiko; Tada, Harue; Teramukai, Satoshi; Mio, Tadashi; Fukushima, Masanori

doi:10.1007/s00280-009-1239-7

Cited by 15 publications

(15 citation statements)

References 25 publications

(28 reference statements)

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“…In addition, a previous study has reported that the combination of 80 mg m −2 S-1 per day for 14 consecutive days and 35 mg m −2 docetaxel on days 1 and 15 every 4 weeks (Figure 1B) in patients with previously treated advanced NSCLC achieved ORRs of 16.3% with median PFS time of 3 months, MST of 9 months, and 1-year survival rates of 42%, respectively (Oki et al , 2011). Our response rates and median PFS time were slightly higher than those of studies reported by Atagi et al , 2008, Yanagihara et al , 2010, and Oki et al , 2011.…”

Section: Discussioncontrasting

confidence: 91%

“…Two previous studies have reported that docetaxel at a dose of 40 mg m −2 on day 1 and S-1 at a dose of 80 mg m −2 per day on days 1–14 every 3 weeks (Figure 1A) in patients with previously treated advanced NSCLC achieved ORRs of 24.1 and 18.4% with median PFS times of 3.9 months and 4.4 months, respectively. Moreover, their MSTs and 1-year survival rates were 11.8 months and 16.1 months, and 42 and 60%, respectively (Atagi et al , 2008; Yanagihara et al , 2010). In addition, a previous study has reported that the combination of 80 mg m −2 S-1 per day for 14 consecutive days and 35 mg m −2 docetaxel on days 1 and 15 every 4 weeks (Figure 1B) in patients with previously treated advanced NSCLC achieved ORRs of 16.3% with median PFS time of 3 months, MST of 9 months, and 1-year survival rates of 42%, respectively (Oki et al , 2011).…”

Section: Discussionmentioning

confidence: 99%

“…Several phase II studies found that the combination of docetaxel and S-1 is effective in patients with NSCLC (Atagi et al , 2008; Yanagihara et al , 2010). These trials employed a combination of docetaxel with oral S-1 for more than 14 consecutive days.…”

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Phase I/II trial of a biweekly combination of S-1 plus docetaxel in patients with previously treated non-small cell lung cancer (KRSG-0601)

et al. 2012

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Background:Combination of S-1, an oral fluorouracil derivative, plus docetaxel against non-small cell lung cancer (NSCLC) showed promising efficacy but clinically problematic emesis. A phase I/II study utilising a new schedule for this combination was conducted.Methods:A biweekly regimen of docetaxel on day 1 with oral S-1 on days 1–7 was administered to previously treated NSCLC patients. Doses of docetaxel/S-1 were escalated to 30/80, 35/80, and 40/80 mg m−2, respectively, and its efficacy was investigated at the recommended dose below maximum tolerated dose (MTD).Results:In phase I study employing 13 patients, dose-limiting toxicities were febrile neutropenia and treatment delay, with the respective MTDs for docetaxel 40 mg m−2/S-1 80 mg m−2. In the phase II study, 34 patients were treated with docetaxel 35 mg m−2/S-1 80 mg m−2 for a median cycle of 6. The response and disease control rates were 34.3% (95% confidence interval (CI), 18.6–50.0%) and 62.9% (95% CI, 46.8–72.9%), respectively. Median progression-free survival was 150.5 days. Haematologic grade 4 toxicities were observed in neutropenia (11.8%) and thrombocytopenia (2.9%). Regarding non-haematologic toxicities, including emesis, there were no grade 3/4 side effects.Conclusion:Combination of 1-week administration of S-1 with biweekly docetaxel is safe and active for NSCLC.

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Section: Discussioncontrasting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

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Phase I/II trial of a biweekly combination of S-1 plus docetaxel in patients with previously treated non-small cell lung cancer (KRSG-0601)

et al. 2012

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“…In chemotherapy-naïve patients, S1 in combination with gemcitabine showed a response rate of 23.1–30.6%, with an MST of 15.5–18.8 months [20]. When combined with docetaxel, a response rate of 18.4%, a median PFS of 4.4 months and an MST of 16.1 months were reported for previously treated NSCLC patients [21]. These results are comparable to those of standard platinum-based regimens.…”

Section: Discussionmentioning

confidence: 99%

A Retrospective Study of the Novel Combination of Paclitaxel and S1 for Pretreated Advanced Non-Small Cell Lung Cancer

Aono¹,

Ito²,

Nishino

et al. 2012

Chemotherapy

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Background: Recently, multiple-line chemotherapy has become popular for non-small cell lung cancer (NSCLC). The survival time of patients is influenced by patient characteristics and subsequent treatments. Methods: The usefulness of paclitaxel plus S1 (PTX+S1) was evaluated in 46 pretreated NSCLC patients. Time from the start of individual regimens till the start of the next one (TNR) was calculated for regimens administered to the study population including PTX+S1 and analyzed by the shared frailty Cox model. Results: The response rate and the median progression-free survival time of PTX+S1 were 32.6% and 253 days, respectively. Substantial difference in TNR was observed in epidermal growth factor receptor mutation status and in line and type of regimens, but not in stage, age, sex, performance status and histology, by univariate analysis. Multivariate analysis revealed that PTX+S1 was only one factor to prolong TNR. Conclusion: Because of long progression-free survival and long TNR, further evaluation of PTX+S1 is necessary.

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“…This meta-analysis showed that postoperative adjuvant chemotherapy with UFT significantly improved 5-and 7-year survival (Hamada et al 2005). Several recent phase II clinical trials suggested that S-1-based chemotherapy showed favorable clinical efficacy and mild toxicities, regardless of treatment with single agent S-1 or an S-1-based combination regimen (Kawahara et al 2001;Yanagihara et al 2010). Therefore, we conducted a metaanalysis to further assess the advantages and toxicity profile of S-1-based chemotherapy versus standard chemotherapy for the treatment of patients with locally advanced or metastatic NSCLC.…”

Section: Introductionmentioning

confidence: 99%

Meta-analysis Exploring the Effectiveness of S-1-Based Chemotherapy for Advanced Non-Small Cell Lung Cancer

Sun

Zhang

et al. 2017

Tohoku J. Exp. Med.

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S-1 is a new oral fluoropyrimidine formulation that comprises tegafur, 5-chloro-2,4-dihydroxypyridine, and potassium oxonate. S-1 is designed to enhance antitumor activity and to reduce gastrointestinal toxicity. Several studies have demonstrated that both S-1 monotherapy and S-1 combination regimens showed encouraging efficacies and mild toxicities in the treatment of lung squamous cell carcinoma and adenocarcinoma. However, it is unclear whether S-1 can be used as standard care in advanced non-small cell lung cancer (NSCLC). The purpose of this meta-analysis was to assess the efficacy and safety of S-1-based chemotherapy, compared with standard chemotherapy, in patients with locally advanced or metastatic NSCLC. Thirteen randomized controlled trials (RCTs) involving 2,134 patients with a similar ratio of different pathological types were included. In first-line or second-line chemotherapy, compared with standard chemotherapy, S-1-based chemotherapy showed similar efficacy in terms of median overall survival (mOS), median progression free survival (mPFS), and objective response rate (ORR) (all P > 0.1), and significantly reduced the incidence of grade ≥ 3 hematological toxicities. In patients with locally advanced NSCLC receiving concurrent chemoradiotherapy, compared with standard chemoradiotherapy, significantly improved survival in the S-1-based chemotherapy was noted in terms of mOS and mPFS (risk radio [RR] = 1.289, P = 0.009; RR = 1.289, P = 0.000, respectively) with lower incidence of grade ≥ 3 neutropenia (RR = 0.453, P = 0.000). The present meta-analysis demonstrates that S-1-based chemotherapy shows similar benefits in advanced NSCLC and improves survival in locally advanced NSCLC, compared with standard treatment.

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Phase II study of S-1 and docetaxel for previously treated patients with locally advanced or metastatic non-small cell lung cancer

Abstract: The combination of S-1 and docetaxel is well tolerable and has substantial activity for patients with locally advanced or metastatic non-small cell lung cancer. A phase III trial comparing docetaxel with or without S-1 would warrant further investigation.

Cited by 15 publications

References 25 publications

Phase I/II trial of a biweekly combination of S-1 plus docetaxel in patients with previously treated non-small cell lung cancer (KRSG-0601)

Phase I/II trial of a biweekly combination of S-1 plus docetaxel in patients with previously treated non-small cell lung cancer (KRSG-0601)

A Retrospective Study of the Novel Combination of Paclitaxel and S1 for Pretreated Advanced Non-Small Cell Lung Cancer

Meta-analysis Exploring the Effectiveness of S-1-Based Chemotherapy for Advanced Non-Small Cell Lung Cancer

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