Platinum rechallenge treatment using gemcitabine plus carboplatin with or without bevacizumab for platinum-resistant ovarian cancer.


Journal

International journal of clinical oncology
ISSN: 1437-7772
Titre abrégé: Int J Clin Oncol
Pays: Japan
ID NLM: 9616295

Informations de publication

Date de publication:
Apr 2022
Historique:
received: 14 03 2021
accepted: 12 12 2021
pubmed: 6 1 2022
medline: 1 4 2022
entrez: 5 1 2022
Statut: ppublish

Résumé

Platinum-resistant ovarian cancer (PROC) is usually treated with single-agent chemotherapy. A synergistic effect of gemcitabine and platinum has been reported in PROC. We evaluated the efficacy and safety of gemcitabine and carboplatin with or without bevacizumab (GC ± B) in patients with PROC. From April 2014 to April 2018, patients with PROC received gemcitabine on days 1 and 8, and carboplatin on day 1, with or without bevacizumab (Bev) on day 1 every 3 weeks. The primary endpoint was objective response rate (ORR). The secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and rate of adverse events. In total, 215 cycles were administered to 31 patients, of whom 21 received Bev and the median number of cycle for each patient was 6 (range, 2-19). The median platinum-free interval (PFI) was 4 months. The ORR and DCR were 51.9% and 92.6%, respectively. Median PFS and OS were 7.9 months and 16.1 months, respectively. PFS and OS of patients with 3-6 months PFI were significantly longer than those with PFI < 3 months (median PFS, 9.7 vs. 5.8 months; p < 0.01; median OS, 20.0 vs. 12.1 months; p = 0.03). Grade 3 or 4 hematological toxicities observed included neutropenia (71.0%), leukopenia (54.8%), anemia (51.6%), and thrombocytopenia (25.8%). No other grade 2-4 nonhematological toxicity was observed except for hypertension in one and CBDCA hypersensitivity reaction in two. GC ± B may be effective and safe treatment alternative for PROC, especially with PFI of 3-6 months, despite hematological toxicity.

Identifiants

pubmed: 34985551
doi: 10.1007/s10147-021-02103-7
pii: 10.1007/s10147-021-02103-7
doi:

Substances chimiques

Deoxycytidine 0W860991D6
Bevacizumab 2S9ZZM9Q9V
Platinum 49DFR088MY
Carboplatin BG3F62OND5
Gemcitabine 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

790-801

Informations de copyright

© 2022. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.

Références

Bray F, Ferlay J, Soerjomataram I et al (2018) Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 68:394–424. https://doi.org/10.3322/caac.21492
doi: 10.3322/caac.21492
National Cancer Registry (Ministry of Health, Labour and Welfare), tabulated by Cancer Information Service, National Cancer Center, Japan. https://ganjoho.jp/reg_stat/statistics/data/dl/en.html
Vital Statistics in Japan, tabulated by Cancer Information Service, National Cancer Center, Japan. https://ganjoho.jp/reg_stat/statistics/data/dl/en.html
Jayson GC, Kohn EC, Kitchener HC et al (2014) Ovarian cancer. Lancet 384:1376–1388. https://doi.org/10.1016/S0140-6736(13)62146-7
doi: 10.1016/S0140-6736(13)62146-7 pubmed: 24767708
Pignata S, Cecere SC, Du Bois A et al (2017) Treatment of recurrent ovarian cancer. Ann Oncol 28:viii51–viii56. https://doi.org/10.1093/annonc/mdx441
doi: 10.1093/annonc/mdx441 pubmed: 29232464
Ushijima K (2010) Treatment for recurrent ovarian cancer—at first relapse. J Oncol. https://doi.org/10.1155/2010/497429
doi: 10.1155/2010/497429 pubmed: 20066162
Mutch DG, Orlando M, Goss T et al (2007) Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol 25:2811–2818. https://doi.org/10.1200/JCO.2006.09.6735
doi: 10.1200/JCO.2006.09.6735 pubmed: 17602086
Gordon AN, Tonda M, Sun S et al (2004) Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol 95:1–8. https://doi.org/10.1016/j.ygyno.2004.07.011
doi: 10.1016/j.ygyno.2004.07.011 pubmed: 15385103
ten Bokkel HW, Lane SR, Ross GA (2004) Long-term survival in a phase III, randomised study of topotecan versus paclitaxel in advanced epithelial ovarian carcinoma. Ann Oncol 15:100–103. https://doi.org/10.1093/annonc/mdh025
doi: 10.1093/annonc/mdh025
Rose PG, Blessing JA, Mayer AR et al (1998) Prolonged oral etoposide as second-line therapy for platinum-resistant and platinum-sensitive ovarian carcinoma: a gynecologic oncology group study. J Clin Oncol 16:405–410. https://doi.org/10.1200/JCO.1998.16.2.405
doi: 10.1200/JCO.1998.16.2.405 pubmed: 9469322
Pujade-Lauraine E, Hilpert F, Weber B et al (2014) Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: the AURELIA open-label randomized phase III trial. J Clin Oncol 32:1302–1308. https://doi.org/10.1200/JCO.2013.51.4489
doi: 10.1200/JCO.2013.51.4489 pubmed: 24637997
Flchtlnger-Schepman AMJ, Van Dijk-knijnenburg HCM, Van Der Velde-visser SD et al (1995) Cisplatin- and carboplatin-DNA adducts: is pt-ag the cytotoxic lesion? Carcinogenesis 16:2447–2453. https://doi.org/10.1093/carcin/16.10.2447
doi: 10.1093/carcin/16.10.2447
McHugh PJ, Spanswick VJ, Hartley JA (2001) Repair of DNA interstrand crosslinks: molecular mechanisms and clinical relevance. Lancet Oncol 2:483–490. https://doi.org/10.1016/S1470-2045(01)00454-5
doi: 10.1016/S1470-2045(01)00454-5 pubmed: 11905724
Wynne P, Newton C, Ledermann JA et al (2007) Enhanced repair of DNA interstrand crosslinking in ovarian cancer cells from patients following treatment with platinum-based chemotherapy. Br J Cancer 97:927–933. https://doi.org/10.1038/sj.bjc.6603973
doi: 10.1038/sj.bjc.6603973 pubmed: 17848946 pmcid: 2360410
D’Agostino G, Amant F, Berteloot P et al (2003) Phase II study of gemcitabine in recurrent platinum-and paclitaxel-resistant ovarian cancer. Gynecol Oncol 88:266–269. https://doi.org/10.1016/S0090-8258(03)00011-8
doi: 10.1016/S0090-8258(03)00011-8 pubmed: 12648573
Ledermann JA, Gabra H, Jayson GC et al (2010) Inhibition of carboplatin-induced DNA interstrand cross-link repair by gemcitabine in patients receiving these drugs for platinum-resistant ovarian cancer. Clin Cancer Res 16:4899–4905. https://doi.org/10.1158/1078-0432.CCR-10-0832
doi: 10.1158/1078-0432.CCR-10-0832 pubmed: 20719935 pmcid: 4283040
Hansen MKG, Smerdel MP, Waldstrøm M et al (2020) Carboplatin re-treatment in platinum-resistant epithelial ovarian cancer patients. Cancer Chemother Pharmacol 86:751–759. https://doi.org/10.1007/s00280-020-04162-5
doi: 10.1007/s00280-020-04162-5 pubmed: 33067703
Eisenhauer EA, Therasse P, Bogaerts J et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45:228–247. https://doi.org/10.1016/j.ejca.2008.10.026
doi: 10.1016/j.ejca.2008.10.026 pubmed: 19097774
John G, Rustin S, Vergote I et al (2011) Definitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and CA 125 agreed by the gynecological cancer intergroup (GCIG). Int J Gynecol Cancer 21:419–423. https://doi.org/10.1097/IGC.0b013e3182070f17
doi: 10.1097/IGC.0b013e3182070f17
Calvert AH, Newell DR, Gumbrell LA et al (1989) Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 7:1748–1756. https://doi.org/10.1200/JCO.1989.7.11.1748
doi: 10.1200/JCO.1989.7.11.1748 pubmed: 2681557
Cockcroft DW, Gault MH (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16:31–41. https://doi.org/10.1159/000180580
doi: 10.1159/000180580 pubmed: 1244564
Aghajanian C, Blank SV, Goff BA et al (2012) OCEANS: A randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 30:2039–2045. https://doi.org/10.1200/JCO.2012.42.0505
doi: 10.1200/JCO.2012.42.0505 pubmed: 22529265 pmcid: 3646321
Greenwood M (1926) The natural duration of cancer. Reports on Public Health and Medical Subjects. London: Her Majesty's Stationery Office. 33:1–26
Ferrandina G, Ludovisi M, Lorusso D et al (2008) Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer. J Clin Oncol 26:890–896. https://doi.org/10.1200/JCO.2007.13.6606
doi: 10.1200/JCO.2007.13.6606 pubmed: 18281662
Brewer CA, Blessing JA, Nagourney RA et al (2006) Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol 103:446–450. https://doi.org/10.1016/j.ygyno.2006.03.018
doi: 10.1016/j.ygyno.2006.03.018 pubmed: 16643994
Sharma R, Graham J, Mitchell H et al (2009) Extended weekly dose-dense paclitaxel/carboplatin is feasible and active in heavily pre-treated platinum-resistant recurrent ovarian cancer. Br J Cancer 100:707–712. https://doi.org/10.1038/sj.bjc.6604914
doi: 10.1038/sj.bjc.6604914 pubmed: 19223898 pmcid: 2653750
Lortholary A, Largillier R, Weber B et al (2012) Weekly paclitaxel as a single agent or in combination with carboplatin or weekly topotecan in patients with resistant ovarian cancer: the CARTAXHY randomized phase II trial from groupe d’investigateurs nationaux pour l’etude des cancers ovariens (GINECO). Ann Oncol 23:346–352. https://doi.org/10.1093/annonc/mdr149
doi: 10.1093/annonc/mdr149 pubmed: 21562072
Oncologico I, Buda A, Floriani I et al (2004) Randomised controlled trial comparing single agent paclitaxel vs epidoxorubicin plus paclitaxel in patients with advanced ovarian cancer in early progression after platinum-based chemotherapy: an Italian collaborative study from the “Mario Negri” Institut. Br J Cancer 90:2112–2117. https://doi.org/10.1038/sj.bjc.6601787
doi: 10.1038/sj.bjc.6601787
Sehouli J, Stengel D, Oskay-oezcelik G et al (2008) Nonplatinum topotecan combinations versus topotecan alone for recurrent ovarian cancer: results of a phase III study of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group. J Clin Oncol 26:3176–3182. https://doi.org/10.1200/JCO.2007.15.1258
doi: 10.1200/JCO.2007.15.1258 pubmed: 18591555
Takasaki K, Miyamoto M, Takano M et al (2018) Addition of bevacizumab to gemcitabine for platinum-resistant recurrent ovarian cancer: a retrospective analysis. Cancer Chemother Pharmacol 81:809–814. https://doi.org/10.1007/s00280-018-3552-5
doi: 10.1007/s00280-018-3552-5 pubmed: 29500481
Nagao S, Kogiku A, Suzuki K et al (2020) A phase II study of the combination chemotherapy of bevacizumab and gemcitabine in women with platinum-resistant recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Ovarian Res 13:1–6. https://doi.org/10.1186/s13048-020-0617-y
doi: 10.1186/s13048-020-0617-y
Takase N, Matsumoto K, Onoe T et al (2015) 4-Step 4-h carboplatin desensitization protocol for patients with gynecological malignancies showing platinum hypersensitivity: a retrospective study. Int J Clin Oncol 20:566–573. https://doi.org/10.1007/s10147-014-0731-1
doi: 10.1007/s10147-014-0731-1 pubmed: 25030546
Inayama Y, Hamanishi J, Matsumura N et al (2018) Antitumor effect of nivolumab on subsequent chemotherapy for platinum-resistant ovarian cancer. Oncologist 23:1382–1384. https://doi.org/10.1634/theoncologist.2018-0167
doi: 10.1634/theoncologist.2018-0167 pubmed: 30158286 pmcid: 6291322
Hamanishi J, Mandai M, Ikeda T et al (2015) Safety and antitumor activity of anti-PD-1 antibody, nivolumab, in patients with platinum-resistant ovarian cancer. J Clin Oncol 33:4015–4022. https://doi.org/10.1200/JCO.2015.62.3397
doi: 10.1200/JCO.2015.62.3397 pubmed: 26351349
Matulonis UA, Santin AD, Lisyanskaya AS et al (2019) Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: results from the phase II KEYNOTE-100 study. Ann Oncol 30:1080–1087. https://doi.org/10.1093/annonc/mdz135
doi: 10.1093/annonc/mdz135 pubmed: 31046082
Liu JF, Herold C, Gray KP et al (2019) Assessment of combined nivolumab and bevacizumab in relapsed ovarian cancer: a phase 2 clinical trial. JAMA Oncol 5:1731–1738. https://doi.org/10.1001/jamaoncol.2019.3343
doi: 10.1001/jamaoncol.2019.3343 pubmed: 31600397 pmcid: 6802049
Domchek SM, Aghajanian C, Shapira-frommer R et al (2016) Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol 140:199–203. https://doi.org/10.1016/j.ygyno.2015.12.020
doi: 10.1016/j.ygyno.2015.12.020 pubmed: 26723501
Pfisterer J, Shannon CM, Baumann K et al (2020) Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol 21:699–709. https://doi.org/10.1016/S1470-2045(20)30142-X
doi: 10.1016/S1470-2045(20)30142-X pubmed: 32305099
Ito K, Nakagawa M, Hori K et al (2020) 834P A phase II study of gemcitabine, cisplatin, and bevacizumab for first recurrent and refractory ovarian clear-cell carcinoma (KCOG-G1601 trial). Ann Oncol 31:S627. https://doi.org/10.1016/j.annonc.2020.08.973
doi: 10.1016/j.annonc.2020.08.973
Poveda AM, Selle F, Hilpert F et al (2015) Bevacizumab combined with weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan in platinum-resistant recurrent ovarian cancer: analysis by chemotherapy cohort of the randomized phase III aurelia trial. J Clin Oncol 33:3836–3838. https://doi.org/10.1200/JCO.2015.63.1408
doi: 10.1200/JCO.2015.63.1408 pubmed: 26282651

Auteurs

Hiroki Nasu (H)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan. nasu_hiroki@med.kurume-u.ac.jp.

Shin Nishio (S)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.

Jongmyung Park (J)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.

Teruyuki Yoshimitsu (T)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.

Ken Matsukuma (K)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.

Kazuto Tasaki (K)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.

Takahiro Katsuda (T)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.

Atsumu Terada (A)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.

Naotake Tsuda (N)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.

Kimio Ushijima (K)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.

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