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Abstract
BackgroundDespite sensitivity to first-line chemotherapy, most small-cell lung cancer (SCLC) patients relapse. In this setting, topotecan demonstrated modest activity with significant toxicity. Paclitaxel was also active. This study was designed to evaluate activity and safety of nab-paclitaxel in relapsed SCLC.MethodsIn this multicentre prospective Phase 2 trial, patients with refractory or sensitive SCLC progressed to first-line platinum-based chemotherapy received nab-paclitaxel 100 mg/smq on days 1, 8, 15 every 4 weeks up to six cycles, progressive disease or intolerable toxicity. Primary endpoint was investigator-assessed objective tumour response. Secondary endpoints were toxicity, progression-free survival (PFS) and overall survival (OS).ResultsOf the 68 patients treated, partial response was 8% in the refractory cohort and 14% in the sensitive cohort. Most common toxicities of any grade were fatigue (54%), anaemia (38%), neutropenia (29%), leukopenia (26%) and diarrhoea (21%). Median PFS was similar in both refractory (1.8 months) and sensitive cohorts (1.9 months), while median OS was longer in sensitive one (6.6 versus 3.6 months).ConclusionsAlthough nab-paclitaxel has shown some modest anti-tumour activity in relapsed SCLC, associated with a favourable toxicity profile, the primary end-point of the study was not met.Clinical Trial registrationClinical Trial registration number is ClinicalTrials.gov Identifier: NCT03219762.
Highlights
Despite sensitivity to first-line chemotherapy, most small-cell lung cancer (SCLC) patients relapse
Patients aged 18 years or older were eligible for study participation if they had a histological or cytological confirmed diagnosis of SCLC, large cell neuroendocrine carcinoma (LCNEC) or undifferentiated neuroendocrine carcinoma of the lung, according to World Health Organization (WHO) classification 2015,21 adequate liver, renal and bone marrow functions, measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1,22 documented radiological evidence of disease progression during or after platinum/etoposide chemotherapy, Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
Patient and treatment characteristics Between February 2017 and March 2018, 72 patients were enrolled into the trial from 18 Italian Centres
Summary
Despite sensitivity to first-line chemotherapy, most small-cell lung cancer (SCLC) patients relapse In this setting, topotecan demonstrated modest activity with significant toxicity. Despite high sensitivity to first-line chemotherapy, most SCLC patients eventually develop disease progression.[3] At relapse, efficacy of secondline treatment is modest and highly influenced by the type and duration of response to prior chemotherapy.[4] Topotecan, the only approved and marketed drug in Europe for the treatment of relapsed SCLC, showed anti-tumour activity (7% and 21.7%)[5,6] and a significant improvement in overall survival (OS) over best supportive care (25.9 weeks versus 13.9 weeks, p = 0.0104).[5,6] it had similar activity (24.3% versus 18.3%)
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