Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL)

Abstract

Background Despite 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. Methods In 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). Results Of 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). Conclusions Although 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 registration Clinical Trial registration number is ClinicalTrials.gov Identifier: NCT03219762.

Weekly nanoparticle albumin-bound paclitaxel and paclitaxel for relapsed small cell lung cancer

“…[10] Recently, a prospective phase II study of nab-PTX in relapsed SCLC showed 8% ORR, 30% DCR, 1.8 months median PFS, and 3.6 months median OS. [11] In our study, survival with both nab-PTX and PTX was comparable to these previous results.…”

Carboplatin plus nab‐paclitaxel for recurrent small cell lung cancer: A phase II study

“…In our study, 57.1% of the patients had received two or more lines of prior treatment, and all the patients had shown progression within 90 days from the end of the prior treatment; in other words, these patients had refractory disease, and this might have resulted in the lower‐than‐expected response rate. Another previous phase II study of nab‐PTX as a single agent for the second‐line treatment of recurrent SCLC had a response rate of 16.0% (90% CI: 6.1%–33.5%), a median OS of 3.65 months (95% CI: 2.07–4.57 months), and a median PFS of 1.84 months (95% CI: 1.02–3.16 months) 24 . Thus, combination chemotherapy with CBDCA plus nab‐PTX might be more efficacious than single agent nab‐PTX.…”

“…Another previous phase II study of nab-PTX as a single agent for the second-line treatment of recurrent SCLC had a response rate of 16.0% (90% CI: 6.1%-33.5%), a median OS of 3.65 months (95% CI: 2.07-4.57 months), and a median PFS of 1.84 months (95% CI: 1.02-3.16 months). 24 Thus, combination chemotherapy with CBDCA plus nab-PTX might be more efficacious than single agent nab-PTX. A Japanese phase II study of amrubicin for the treatment of refractory SCLC resulted in a response rate of 32.9% (95% CI: 22.9%-44.2%) and a median OS of 8.9 months.…”

Standard therapy‑resistant small cell lung cancer showing dynamic transition of neuroendocrine fate during the cancer trajectory: A case report

“…In the present case, nab-paclitaxel may have contributed to the therapeutic effect, as it is unlikely that continuous use of carboplatin or the switch from atezolizumab to pembrolizumab resulted in the marked antitumor effect. However, nab-paclitaxel shows modest antitumor activity only in a small proportion of relapsed SCLC (17). Further investigations are needed to elucidate the background of SCLC tumors that are sensitive to nab-paclitaxel.…”