Paclitaxel-carboplatin and bevacizumab combination with maintenance bevacizumab therapy for metastatic, recurrent, and persistent uterine cervical cancer: An open-label multicenter phase II trial (JGOG1079)

Tanigawa, Terumi; Takeshima, Nobuhiro; Ishikawa, Hideki; Nishio, Yukihiro; Usami, Tomoka; Yamawaki, Takaharu; Oishi, Tsutomu; Ihira, Kei; Kato, Hiroyuki; Goto, Mayako; Saito, Motoaki; Taira, Yoichi; Yokoyama, Masatoshi; Shoji, Tadahiro; Kondo, Eiji; Mori, Atsushi; Yokoi, Takeshi; Iwasa-Inoue, Naomi; Hirashima, Yasuyuki; Nagasawa, Takayuki; Takenaka, Motoki; Mikami, Mikio; Sugiyama, Toru; Enomoto, Takayuki

doi:10.1016/j.ygyno.2022.04.011

Cited by 9 publications

(7 citation statements)

References 23 publications

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“…In the JGOG1079 study in Japan, it was reported that bevacizumab maintenance therapy prolonged PFS (14.3 months vs. 7.4 months; p=0.0449) and OS (23.5 months vs. 20.4 months; p=0.0232) over the observation time (median 17.7 months). However, the median OS had not been reached [ 4 ]. In the JO29569 study in Japan, 5 out of 7 patients received bevacizumab maintenance therapy following TP plus bevacizumab [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

“…This outcome was similar to that of the CECILIA study (11.3%) [ 16 ] and a multicenter study in the Kinki district of Japan (11.2%) [ 19 ]. A medical history of pelvic radiotherapy was considered a risk factor for fistula and intestinal perforation, as previously reported [ 2 4 16 19 20 ]. These studies reported that the rate of fistula formation or intestinal perforation in previously irradiated patients was 84%–100%.…”

Section: Discussionmentioning

confidence: 99%

“…Currently, 2 reports have focused on this clinical question. In the JGOG1079 study, bevacizumab maintenance therapy for patients presenting a complete or partial response after TC plus bevacizumab therapy improved PFS [ 4 ]. However, the efficacy of bevacizumab maintenance therapy was not the primary or secondary endpoint of the JGOG1079 study.…”

Section: Introductionmentioning

confidence: 99%

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Real-world efficacy and safety of bevacizumab single-maintenance therapy following platinum-paclitaxel chemotherapy plus bevacizumab in patients with advanced cervical cancer

et al. 2023

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Objective Bevacizumab maintenance therapy following platinum-based combination chemotherapy for metastatic, recurrent, or persistent cervical cancer is not recommended as standard therapy. This pilot study aimed to evaluate the efficacy and safety of bevacizumab maintenance therapy and the contribution of the platinum-free interval to the efficacy of subsequent chemotherapy for advanced cervical cancer. Methods We retrospectively identified 115 patients with metastatic, recurrent, or persistent cervical cancer treated with platinum-paclitaxel chemotherapy plus bevacizumab at 7 institutions between 2015 and 2020. The primary endpoints were overall survival (OS) and progression-free survival (PFS) in patients who received bevacizumab maintenance therapy and those who did not. We also analyzed the adverse events associated with bevacizumab and survival time from the start of subsequent chemotherapy in both groups. Results Following platinum-paclitaxel plus bevacizumab chemotherapy, 34 patients received bevacizumab maintenance therapy and 81 patients did not. Of the 115 patients, 56 received chemotherapy for subsequent relapse. Although bevacizumab maintenance therapy prolonged PFS (median of 16.0 months vs. 9.0 months, p=0.041), significant differences were not observed in OS (p=0.374). Furthermore, bevacizumab maintenance therapy did not prolong OS and PFS after the start of subsequent chemotherapy (p=0.663 and p=0.136, respectively). Bevacizumab maintenance therapy significantly increased hypertension (p=0.035) and proteinuria (p=0.005) but did not cause complications leading to death. Conclusion Bevacizumab single-maintenance therapy for advanced cervical cancer can be considered in selected cases, such as those with acceptable bevacizumab-related side effects. The outcomes of our study will likely contribute to decision-making regarding practical treatment strategies.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Real-world efficacy and safety of bevacizumab single-maintenance therapy following platinum-paclitaxel chemotherapy plus bevacizumab in patients with advanced cervical cancer

et al. 2023

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“…Those whose tumors are resistant or refractory to these agents will soon represent an area of unmet clinical need. While GOG-240 and phase II studies showed that patients with persistent or recurrent tumors after concurrent cisplatin-RT retain sensitivity towards platinum (when combined with paclitaxel ± bevacizumab) [ 35 36 37 ], post-INTERLACE patients cannot be assumed to respond favorably to paclitaxel–carboplatin re-treatment in the palliative setting, except probably those with long treatment-free intervals. In this post-INTERLACE/KEYNOTE-A18 paradigm, trials evaluating ADCs, passive immunotherapies (including anti-PD-L1 inhibitors and bispecific antibodies) or active immunotherapies (e.g.…”

Section: Future Directionsmentioning

confidence: 99%

Evolving standards and future directions for systemic therapies in cervical cancer

Ang,

Chan

2024

J Gynecol Oncol

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Several groundbreaking clinical trials with the potential to transform the management paradigm of both locally advanced and persistent, recurrent, or metastatic cervical cancers have been presented in 2023. This review describes the reported data from INTERLACE and KEYNOTE-A18 in the locally advanced setting, as well as BEATcc, innovaTV 301 and DESTINY-PanTumor02 for advanced disease. The practice implications of their positive results are interpreted in the context of global health considerations, and updated treatment algorithms are proposed. Furthermore, emerging trends in drug development for cervical cancer are discussed. As the routine use of immune checkpoint inhibitors (ICIs) for curative and palliative indications increases in the foreseeable future, patients whose cervical cancers which persist, relapse or progress after prior ICI exposure will represent an area of unmet clinical need and form the key target population for next-generation trials. Future research will help shape oncologists’ approaches in the optimal selection, sequencing and re-treatment or rechallenge of immuno-oncology agents and/or antibody-drug conjugates in women with cervical cancer.

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“…Currently, various clinical treatment modalities are available for cervical cancer, including surgery and radiotherapy. In early-stage cases, total hysterectomy with pelvic lymph node dissection is commonly performed due to its associated favorable treatment outcomes and longer survival [2,3]. However, in cases where cervical cancer progresses to intermediate or advanced stages, achieving optimal results through surgery becomes challenging.…”

Section: Introductionmentioning

confidence: 99%

Comparison of the clinical efficacy of paclitaxel + carboplatin and paclitaxel + cisplatin on tumor markers and WHOQOL-BREF score on cervical cancer patients

2023

EJGO

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This study aims to compare tumor marker indicators, World Health Organization Quality of Life-Brief assessment (WHOQOL-BREF) scores and clinical outcomes between cervical cancer patients treated with paclitaxel + carboplatin versus those treated with paclitaxel + cisplatin. 66 cervical cancer patients admitted to our hospital were randomly selected and allocated equally into a control group (paclitaxel + cisplatin) and a study group (paclitaxel + carboplatin) using a randomized double-blinded approach. Tumor marker indices, WHOQOL-BREF scores, Karnofsky Performance Status (KPS) scores, clinical outcomes and adverse effects were assessed and compared before and after treatment. The study group was found to have lower carcino-embryonic antigen (CEA), Carbohydrate antigen (CA) 199, CA125 and CA50 levels, significantly higher WHOQOL-BREF scores, and significantly higher KPS scores at 7 days, 1 month, 2 months and 3 months post-treatment compared to the control group (all p < 0.05). However, we also observed that while the treatment effectiveness rate in the study group (75.76%) surpassed that in the control group (66.67%), the difference was statistically significant (p > 0.05). Patients in the study group had a statistically significant lower incidence of diarrhea (45.45%) and nausea and vomiting (48.48%) compared to the control group, whose corresponding rates were higher at 69.70% and 75.76%, respectively (χ 2 = 3.969, 5.215, p = 0.046, 0.022). Conversely, the incidence of bone marrow suppression in the study group (48.48%) was significantly higher than that in the control group (21.21%) (χ 2 = 4.405, p = 0.020). We conclude that the combination of paclitaxel and carboplatin was an effective treatment approach for cervical cancer patients, offering comparative advantages over paclitaxel + cisplatin, with reduced tumor marker levels, enhanced quality of life, and minimized adverse reaction occurrence.

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Paclitaxel-carboplatin and bevacizumab combination with maintenance bevacizumab therapy for metastatic, recurrent, and persistent uterine cervical cancer: An open-label multicenter phase II trial (JGOG1079)

Cited by 9 publications

References 23 publications

Real-world efficacy and safety of bevacizumab single-maintenance therapy following platinum-paclitaxel chemotherapy plus bevacizumab in patients with advanced cervical cancer

Real-world efficacy and safety of bevacizumab single-maintenance therapy following platinum-paclitaxel chemotherapy plus bevacizumab in patients with advanced cervical cancer

Evolving standards and future directions for systemic therapies in cervical cancer

Comparison of the clinical efficacy of paclitaxel + carboplatin and paclitaxel + cisplatin on tumor markers and WHOQOL-BREF score on cervical cancer patients

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