Dataset Information

S-1 Maintenance Therapy in Extensive Stage Small-Cell Lung Cancer-A Randomized Clinical Study.

ABSTRACT: Small-cell lung cancer (SCLC) is a recalcitrant cancer for its dismal prognosis although extensive research had been done. Four to 6 cycles platinum-based chemotherapy is the mainstay treatment for the extensive-stage disease; but the role of maintenance treatment is not fully understood. This is a phase 2, open-label study. Patients with extensive-stage SCLC reaching an objective response or stable disease (SD) after induction chemotherapy were randomly assigned (1:1) with a minimization procedure. One group received oral S-1 and the other group received placebo as maintenance treatment until disease progression or unacceptable toxicities. The primary end point of this study was progression-free survival (PFS), and the secondary end points were overall survival (OS), response rates, and toxicities. This study was based on earlier work, the preliminary results was reported on 2019 ASCO annual meeting. A total of 89 patients were enrolled, of whom 45 received S-1 maintenance therapy and 44 received placebo. The median PFS and OS were 6.35 months and 10.82 months in the S-1 group, as compared to 5.98 months and 10.09 months in the placebo group. The PFS was 7.2 months and 5.3 months, and OS was 12.9 months and 10.9 months in patients with an objective response compared to in patients with SD after induction chemotherapy, respectively. S-1 maintenance therapy did not prolong PFS or OS in patients with extensive-stage SCLC; tumor regression rate was the prognostic factor of PFS or OS. Further research with novel agents in the maintenance setting is warranted.

SUBMITTER: Nie K

PROVIDER: S-EPMC7307401 | biostudies-literature | 2020 Apr-Jun

REPOSITORIES: biostudies-literature

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S-1 Maintenance Therapy in Extensive Stage Small-Cell Lung Cancer-A Randomized Clinical Study.

Nie Keke K Guo Xiuhui X You Yunhong Y Zhuang Xingjun X Zhang Chunling C Ji Youxin Y

Cancer control : journal of the Moffitt Cancer Center 20200401 2

Small-cell lung cancer (SCLC) is a recalcitrant cancer for its dismal prognosis although extensive research had been done. Four to 6 cycles platinum-based chemotherapy is the mainstay treatment for the extensive-stage disease; but the role of maintenance treatment is not fully understood. This is a phase 2, open-label study. Patients with extensive-stage SCLC reaching an objective response or stable disease (SD) after induction chemotherapy were randomly assigned (1:1) with a minimization proced ...[more]

PMID: 32551853

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Project description:BackgroundDue to the high incidence and mortality of lung cancer, and etoposide is the standard first-line chemotherapy for small cell lung cancer, to evaluate the efficacy and safety of etoposide capsules at different doses as maintenance therapy for patients with extensive-stage small cell lung cancer (ES-SCLC) who show a response to etoposide plus platinum.MethodsThe study was divided into two stages: stage I, a single-center, one-arm prospective study, and stage II, a multicenter, controlled non-randomized prospective study (patients were chosen from ClinicalTrials.gov Identifier: NCT02179528). All patients received six cycles of etoposide plus platinum. Patients who were evaluated as complete remission (CR) or partial remission (PR) entered the maintenance treatment (MT) (etoposide capsule, once a day for 20 days, every 28 days as a cycle, until disease progression). In stage I, the dose of etoposide was 25 mg; in stage II, patients were non-randomized into etoposide capsule (25 mg/50 mg) and observation groups. In this study, the primary endpoints were progression-free survival (PFS) and safety; the secondary endpoint was overall survival (OS). Toxicity was graded according to the Common Terminology Criteria for Adverse Events v3.0.ResultsNinety-two patients were enrolled. In stage I, the median PFS was 6.700 months (95% CI: 6.408-6.992). In stage II, the median PFS of the MT group was better than that in the NMT group (8.930 vs. 5.900 months, P=0.002). In the pooled analysis, the overall median PFS of the MT group was better than that of the NMT group (7.870 vs. 5.900 months, P=0.003). However, there was no significant difference in OS between the groups (15.030 vs. 14.330 months, P=0.813). Multivariate Cox regression analysis showed that maintenance therapy was an independent protective factor for PFS in patients with ES-SCLC.ConclusionsEtoposide capsules as maintenance therapy significantly prolonged the PFS of patients with ES-SCLC who responded to etoposide plus platinum, with acceptable tolerability.

Project description:The prevalence of small cell lung cancer (SCLC) has declined in the U.S. as the prevalence of tobacco use has declined. However, a significant number of people in the U.S. are current or former smokers and are at risk of developing SCLC. Routine histological or cytological evaluation can reliably make the diagnosis of SCLC, and immunohistochemistry stains (thyroid transcription factor-1, chromogranin, synaptophysin, and CD56) can be used if there is uncertainty about the diagnosis. Rarely do patients present with SCLC amendable to surgical resection, and evaluation requires a meticulous workup for extra-thoracic metastases and invasive staging of the mediastinum. Resected patients require adjuvant chemotherapy and/or thoracic radiation therapy (TRT), and prophylactic cranial radiation (PCI) should be considered depending on the stage. For limited-stage disease, concurrent platinum-etoposide and TRT followed by PCI is the standard. Thoracic radiation therapy should be started early in treatment, and can be given twice daily to 45 Gy or once daily to 60-70 Gy. For extensive-stage disease, platinum-etoposide remains the standard first-line therapy, and the standard second-line therapy is topotecan. Preliminary studies have demonstrated the activity of immunotherapy, and the response rate is approximately 10-30% with some durable responses observed. Rovalpituzumab tesirine, an antibody drug conjugate, has shown promising activity in patients with high delta-like protein 3 tumor expression (approximately 70% of patients with SCLC). The emergence of these and other promising agents has rekindled interest in drug development in SCLC. Several ongoing trials are investigating novel agents in the first-line, maintenance, and second-line settings.This review will provide an update on the standard therapies for surgically resected limited-stage small cell lung cancer and extensive-stage small cell lung cancer that have been investigated in recent clinical trials.

Dataset Information

S-1 Maintenance Therapy in Extensive Stage Small-Cell Lung Cancer-A Randomized Clinical Study.

Publications

S-1 Maintenance Therapy in Extensive Stage Small-Cell Lung Cancer-A Randomized Clinical Study.

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