Solvent-based paclitaxel or nab-paclitaxel for heavily treated relapsed/refractory small cell lung cancer

Sugiyama, Keiji; Kogure, Yoshihito; Torii, Atsushi; Shiraishi, Kazuhiro; Yamada, Ayaka; Ishida, Akane; Shigematsu, Fumie; Nozawa, Kazuki; Niwa, Hideyuki; Oka, Saori; Nakahata, Masashi; Kitagawa, Chiyoe; Oki, Masahide; Sasaki, Hideo

doi:10.1097/md.0000000000014758

Cited by 10 publications

(18 citation statements)

References 21 publications

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“…Similarly, a retrospective analysis reported outcome of 31 heavily pre-treated Japanese SCLC patients of whom only 4 received nab-paclitaxel, preventing any meaningful consideration on the efficacy of this agent. 20 In our study, the discordance in terms of ORR between local and central assessment has been mainly due, at least in some cases, to an improper application of RECIST v1.1 by local radiologists. For example, two refractory patients considered as stable were reclassified as responders after central radiological review because of a misleading interpretation of two target liver lesions in one case and two pathological mediastinal lymph nodes in the other one.…”

Section: Discussionmentioning

confidence: 58%

“…Three Asian retrospective analyses conducted in relapsed SCLC patients showed some anti-cancer activity of nab-paclitaxel. [18][19][20] Since nab-paclitaxel has not been prospectively studied in relapsed SCLC yet, we designed this open-label, prospective Phase 2 trial with the aim to assess its activity and safety in patients with both refractory and sensitive disease.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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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.

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Section: Discussionmentioning

confidence: 58%

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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“…However, it responded to the nab-paclitaxel-containing regimen. There have been several reports of paclitaxel or nab-paclitaxel showing antitumor activity against SCLC (15,16). 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.…”

Section: Discussionmentioning

confidence: 60%

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

et al. 2021

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While small cell lung cancer (SCLC) has been treated as a single disease historically, recent studies have suggested that SCLC can be classified into molecular subtypes based on the expression of lineage transcription factors such as achaete-scute homolog 1 (ASCL1), neurogenic differentiation factor 1 (NEUROD1), POU domain class 2 transcription factor 3 (POU2F3) and transcriptional coactivator YAP1 (YAP1). These transcription factor-based subtypes may be specifically targeted in therapy, and recent studies have suggested that the SCLC subtypes represent different stages of dynamic evolution of SCLC rather than independent diseases. Nevertheless, evidence of shift in neuroendocrine differentiation during SCLC evolution has been lacking in the clinical setting. In the present study, a 60-year-old male was diagnosed with extensive SCLC. The tumor responded not to the standard SCLC regimen of carboplatin, etoposide and atezolizumab, but to the non-SCLC regimen of carboplatin, nab-paclitaxel and pembrolizumab. The patient succumbed 5 months after the initial diagnosis and a pathological autopsy was performed. The tumor was originally negative for all four transcription factors, ASCL1, NEUROD1, POU2F3 and YAP1, in the biopsy specimens at diagnosis. Loss of synaptophysin expression and emergence of Myc proto-oncogene protein and YAP1 expression was recorded in the autopsy specimens, suggesting the transition to a decreased neuroendocrine fate during the disease trajectory. This case provides clinical evidence of dynamic transition of neuroendocrine fate during SCLC evolution. In light of SCLC heterogeneity and plasticity, development of precision medicine is required.

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“…Nab‐paclitaxel is generally recognized as a relatively mild chemotherapeutic agent with good tolerability compared with other chemotherapy regimens in various solid tumors, including NSCLC . Clinical trials showed that nab‐paclitaxel had better efficacy and safety than sb‐paclitaxel …”

Section: Discussionmentioning

confidence: 99%

“…The multivariable analyses showed that ECOG performance status of 1 (vs. 2) and age of 70–74 years (vs. 65–69) were independently associated with longer OS, while early treatment line of nab‐paclitaxel (first‐line vs. second‐line, first‐line vs. third‐ or further‐line) and age of 70–74 years (vs. 65–69) were independently associated with longer PFS. Sugiyama et al . identified the performance status and high lactate dehydrogenase levels as the independent predictors of poor OS in patients with refractory/relapsed NSCLC treated with nab‐paclitaxel.…”

Section: Discussionmentioning

confidence: 99%

Retrospective analysis of the effectiveness and tolerability of nab‐paclitaxel in Chinese elderly patients with advanced non‐small‐cell lung carcinoma

et al. 2020

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Background: Previous trials have suggested that elderly patients with non-small-cell lung cancer (NSCLC) could benefit from nanoparticle albumin-bound paclitaxel (nab-paclitaxel). Real-world data on the elderly Chinese population are lacking. This study aimed to analyze the effectiveness and tolerability of nab-paclitaxel in Chinese elderly patients (≥65 years) with advanced NSCLC. Methods: This study included 76 patients with a primary diagnosis of IIIB-IV NSCLC from January 2010 to December 2017 at Peking University Cancer Hospital, who received nab-paclitaxel (125 or 130 mg/m 2 i.v.) every three weeks. The overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) were analyzed. Results: There were 12 patients who received nab-paclitaxel as the first-line treatment (seven also received carboplatin), and 64 received nab-paclitaxel as the latter-line treatment. The overall ORR, DCR, median PFS, and median OS were 14.5%, 69.7%, 5.2 months, and 12.2 months, respectively. The Eastern Cooperative Oncology Group performance status of one and the age of 70-74 years were independently associated with longer OS, while early treatment line of nabpaclitaxel and age of 70-74 years were independently associated with longer PFS. The most common AEs were anemia, leukopenia, gastrointestinal reaction, fatigue, and peripheral neuropathy, which were all manageable. Dose adjustment or treatment discontinuation was encountered in 10 patients because of AEs. The incidence of AEs was not different among age subgroups. Conclusions: Nab-paclitaxel has a good clinical response profile in Chinese elderly patients with stage IIIB-IV NSCLC. Prospective clinical trials are needed to confirm these results. Key pointsSignificant findings of the study: Nanoparticle albumin-bound paclitaxel (nabpaclitaxel) has a good clinical response profile in Chinese elderly (≥65 years) patients with stage IIIB-IV non-small-cell lung cancer (NSCLC), with acceptable and manageable adverse events. What this study adds: Preliminary evidence shows a good clinical response from treatment with nab-paclitaxel in Chinese elderly patients with advanced NSCLC.

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Solvent-based paclitaxel or nab-paclitaxel for heavily treated relapsed/refractory small cell lung cancer

Cited by 10 publications

References 21 publications

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

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

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

Retrospective analysis of the effectiveness and tolerability of nab‐paclitaxel in Chinese elderly patients with advanced non‐small‐cell lung carcinoma

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