Journal article
Phase II study of nab-paclitaxel with gemcitabine for relapsed/refractory small cell lung cancer
Frontiers in oncology, Vol.14, 1303268
07/31/2024
DOI: 10.3389/fonc.2024.1303268
PMCID: PMC11322450
PMID: 39144826
Abstract
Background Patients with small cell lung cancer (SCLC) often respond to first-line chemoimmunotherapy. However, relapse is inevitable and is associated with a poor prognosis. Treatments for relapsed SCLC, such as lurbinectedin and topotecan, are limited by modest efficacy and significant hematologic adverse events, leaving a need for newer therapeutic agents or regimens. The combination of gemcitabine and nab-paclitaxel is active and safe in other types of malignancies, such as pancreatic cancer. Patients and methods We conducted a phase II trial evaluating the efficacy and safety of gemcitabine and nab-paclitaxel in patients with relapsed/refractory SCLC. The primary endpoint was objective response rate (ORR), defined as the proportion of patients with confirmed complete or partial response. Secondary endpoints included time to progression (TTP), progression-free survival (PFS), overall survival (OS), and safety. Results Between October 2016 and May 2021, 32 patients were enrolled. Patients were followed for a median of 9.3 months (range 1.8–65.2). Median age was 65 years (range 48–81). Fifty percent of patients were female. Fifty-three percent of patients had platinum-resistant/refractory relapsed SCLC. The ORR was 28.1% (95% confidence interval [CI] 15.5–100%). Median PFS was 2.9 months (95% CI 2.4–3.6), and median OS was 9.3 months (95% CI 5.2–12.4). Seven patients (21.9%) developed grade 3 or 4 neutropenia. Conclusion Our study showed that the combination of gemcitabine and nab-paclitaxel led to encouraging outcomes in relapsed/refractory SCLC. Further studies are needed to compare this combination with other treatments used for relapsed SCLC, including lurbinectedin, temozolomide, and topotecan. Clinical trial registration https://clinicaltrials.gov/study/NCT02769832?cond=NCT02769832&rank=1 , identifier NCT02769832.
Details
- Title: Subtitle
- Phase II study of nab-paclitaxel with gemcitabine for relapsed/refractory small cell lung cancer
- Creators
- Margaret M. ByrneGrerk SutamtewagulWilliam ZeitlerSarah L. MottGideon K.D. ZambaArsenije KojadinovicJun ZhangTaher Abu-HejlehGerald ClamonMuhammad Furqan
- Resource Type
- Journal article
- Publication Details
- Frontiers in oncology, Vol.14, 1303268
- Publisher
- FRONTIERS MEDIA SA; LAUSANNE
- DOI
- 10.3389/fonc.2024.1303268
- PMID
- 39144826
- PMCID
- PMC11322450
- ISSN
- 2234-943X
- eISSN
- 2234-943X
- Grant note
We wish to thank all the patients, family members, and research staff that participated in the study.DAS:The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s.
- Language
- English
- Date published
- 07/31/2024
- Academic Unit
- Radiology; Hematology, Oncology, and Blood & Marrow Transplantation; Biostatistics; Internal Medicine
- Record Identifier
- 9984691438102771
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