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Original research
Efficacy and toxicity of carboplatin and gemcitabine administered on day 1 and day 8 (day1&8) versus day 1-only for platinum-sensitive recurrent epithelial ovarian cancer
  1. Erika J Lampert1,
  2. Peter G Rose2,
  3. Meng Yao3,
  4. Robert DeBernardo2,
  5. Roberto J Vargas2,
  6. Chad M Michener2 and
  7. Laura M Chambers2,4
  1. 1Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, Ohio, USA
  2. 2Division of Gynecologic Oncology, Cleveland Clinic, Cleveland, Ohio, USA
  3. 3Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, USA
  4. 4Division of Gynecologic Oncology, The Ohio State University, Columbus, Ohio, USA
  1. Correspondence to Dr Erika J Lampert, Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, OH 44195, USA; ejlampert{at}gmail.com

Abstract

Objective To compare response rate, progression-free survival, overall survival, and toxicity of carboplatin and gemcitabine administered on day 1 and day 8 (day1&8) versus a modified day 1-only regimen in recurrent platinum-sensitive ovarian cancer.

Methods A retrospective single-institution cohort study was performed in women with recurrent platinum-sensitive ovarian cancer between January 2009 and December 2020 treated with carboplatin and gemcitabine on a 21-day cycle. The impact of dosing schedule on response rate, progression-free survival, overall survival, and toxicities was assessed with univariate and multivariate models.

Results Of 200 patients, 26% (n=52) completed day 1&8, 21.5% (n=43) started day 1&8 but dropped day 8, and 52.5% (n=105) received day 1-only. There were no differences in demographics. Median starting carboplatin and gemcitabine doses were area under curve (AUC) 5 and 600 mg/m2 for day 1-only versus AUC4 and 750 mg/m2 among day 1&8, respectively (p<0.001). A total of 43 patients (45.3%) dropped day 8 primarily due to neutropenia (51.2%) or thrombocytopenia (30.2%). The response rates were 69.3% for day 1&8-completed, 67.5% for day 1&8-dropped, and 67.6% for day 1-only (p=0.92). Median progression-free survival was 13.1, 12.1, and 12.4 months for day 1&8-completed, day 1&8-dropped, and day 1-only, respectively (p=0.29). Median overall survival was 28.2, 33.5, and 34.3 months for the above groups (p=0.42). The rate of grade 3/4 hematologic toxicity (48.9% vs 31.4%, p=0.002), dose reductions (58.9% vs 33.7%, p<0.001), blood transfusions (22.1% vs 10.5%, p=0.025), and treatment with pegfilgrastim (64.2% vs 51%, p=0.059) were higher among day 1&8 versus day 1-only, respectively.

Conclusions There was no difference in response rate, progression-free survival, or overall survival for day 1&8 versus day 1-only, regardless of whether day 8 was dropped. Day 1&8 was associated with greater hematologic toxicity. A modified day 1-only regimen may represent an alternative to day 1&8 and warrants prospective study.

  • ovarian cancer

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/ijgc-2022-004199

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @ErikaJLampert, @laurajmoulton

    • Presented at These findings were partially presented in abstract format at the 2022 Annual Meeting of the American Society of Clinical Oncology in June 2022.

    • Contributors LMC, PGR, RD, RJV, and CMM provided the conceptualization and methodology of the study. EJL and LCM performed data collection. EJL and MY performed data analysis. EJL and LMC wrote the main manuscript text. LMC is the guarantor. All authors reviewed and edited the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.