scholarly journals A Modified Intraperitoneal Chemotherapy Regimen for Ovarian Cancer: Technique and Treatment Outcomes

Cancers ◽  
2021 ◽  
Vol 13 (19) ◽  
pp. 4886
Author(s):  
Ji Hyun Kim ◽  
Hyeong In Ha ◽  
Min Hae Kim ◽  
Mi Ra Han ◽  
Sang-Yoon Park ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Treatment Outcomes ◽  
Chemotherapy Regimen ◽  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Completion Rate ◽  
Study Cohort ◽  
Colonic Surgery ◽  
Gynecologic Oncology Group ◽  
Primary Ovarian Cancer

This study aimed to investigate treatment outcomes concerning three institutional modifications to intraperitoneal (IP) chemotherapy for patients with ovarian cancer. The medical records of 27 patients treated with IP chemotherapy were retrospectively reviewed. All patients had three IP chemotherapy institutional modifications; modified Gynecologic Oncology Group 172 regimen was used for the chemotherapy regimen. With institutional modifications, 63.0% (17/27) completed all six cycles of IP chemotherapy. Of the 17 and 10 patients with primary and recurrent ovarian cancer, respectively, 55.6% (15/27) underwent left colonic surgery, including low anterior resection. In patients with primary ovarian cancer, the IP chemotherapy completion rate was 76.5% (13/17). In patients with and without left colonic surgery, the IP chemotherapy completion rates were 53.3% (8/15) and 75.0% (9/12), respectively. No complications related to left colonic surgery during IP chemotherapy were identified. The most frequent grade 3–4 toxicities were gastrointestinal toxicities (33.3%) and neutropenia (29.6%). The median progression-free survival was 19.5 months in all patients and 25.2 months in patients with primary ovarian cancer. Three institutional modifications to IP chemotherapy increased the completion rate for planned IP chemotherapy, even after left colonic surgery. Further studies involving a larger study cohort are required to confirm survival outcomes using these modifications.

scholarly journals Bevacizumab use in the frontline, maintenance and recurrent settings for ovarian cancer

2020 ◽  
Vol 16 (7) ◽  
pp. 225-246 ◽  
Author(s):  
Carolyn E Haunschild ◽  
Krishnansu S Tewari
Keyword(s):  
Ovarian Cancer ◽  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Double Blind ◽  
Free Survival ◽  
Platinum Sensitive ◽  
The Us ◽  
Us Fda

On 13 June 2018, Genentech, Inc. issued a press release announcing that the US FDA had approved the antiangiogenesis drug, bevacizumab, in combination with chemotherapy for frontline and maintenance therapy for women with newly diagnosed ovarian cancer. Regulatory approval was based on the National Cancer Institute-sponsored Gynecologic Oncology Group (GOG) protocol 0218, the Phase III, randomized, placebo-controlled, double-blind, multi-center and multi-national clinical trial that met its primary end point, progression-free survival. Bevacizumab is now approved in the frontline, platinum-sensitive recurrent and platinum-resistant recurrent settings for epithelial ovarian cancer. This review will address the broad range of clinical trials addressing the efficacy of bevacizumab use in ovarian cancer.

scholarly journals Counterpoint: Intraperitoneal Chemotherapy: An Investigational Treatment in Ovarian Cancer

2004 ◽  
Vol 2 (6) ◽  
pp. 555-560 ◽  
Author(s):  
Robert F. Ozols
Keyword(s):  
Ovarian Cancer ◽  
Standard Therapy ◽  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Systemic Circulation ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Oncology Group ◽  
Phase Ii Trials

Intraperitoneal (IP) chemotherapy in ovarian cancer has been studied since 1978. Numerous phase II trials have been performed, which have shown that higher levels can be obtained in the peritoneal cavity compared with systemic circulation after administration of cytoxic agents in a large volume via a semi-permanent catheter. Three randomized trials have been performed in patients with ovarian cancer comparing different IP regimens to standard therapy with intravenous agents. The last two trials from the Gynecologic Oncology Group (GOG) and the Southwest Oncology Group (SWOG) compared two different IP regimens versus standard therapy with intravenous cisplatin plus paclitaxel. Although an improvement in progression-free survival was reported for the IP regimens, they have been associated with unacceptable toxicity, and no IP regimen can be considered standard therapy. Maintenance therapy with IP cisplatin also failed to improve survival in patients who obtained complete remission after intravenous chemotherapy. The GOG is considering another phase III trial of IP therapy that will compare a carboplatin-based regimen versus standard therapy with intravenous paclitaxel plus carboplatin. Unless such a trial shows an improvement in clinical outcome, intravenous carboplatin plus paclitaxel remains the standard of care and IP chemotherapy should not be used outside of a clinical trial.

Phase III Randomized Study of Cisplatin Versus Paclitaxel Versus Cisplatin and Paclitaxel in Patients With Suboptimal Stage III or IV Ovarian Cancer: A Gynecologic Oncology Group Study

2000 ◽  
Vol 18 (1) ◽  
pp. 106-106 ◽  
Author(s):  
Franco M. Muggia ◽  
Patricia S. Braly ◽  
Mark F. Brady ◽  
Gregory Sutton ◽  
Theodore H. Niemann ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Combination Therapy ◽  
Death Rate ◽  
Gynecologic Oncology ◽  
Randomized Study ◽  
Progression Free Survival ◽  
Complete Response ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Treatment Groups

PURPOSE: To assess progression-free survival (PFS) and overall survival (OS) in patients with suboptimally debulked epithelial ovarian cancer receiving cisplatin (100 mg/m2) or 24-hour infusion paclitaxel (200 mg/m2) or the combination of paclitaxel (135 mg/m2) followed by cisplatin (75 mg/m2). PATIENTS AND METHODS: After stratification for disease measurability, patients were randomized to receive six cycles of one of the treatments every 3 weeks. If measurable, complete response (CR) or partial response (PR) was determined. RESULTS: Six hundred fourteen of 648 patients who entered onto the trial were eligible. Monotherapies were discontinued more frequently (cisplatin because of toxicity or patient refusal [17%], and paclitaxel because of progression [20%]) compared with the combination therapy (7% and 6%, respectively). Neutropenia, fever, and alopecia were more severe with paclitaxel-containing regimens; whereas anemia, thrombocytopenia, neurotoxicity, nephrotoxicity, and gastrointestinal toxicity were more severe with cisplatin-containing regimens. The CR/PR rates on paclitaxel monotherapy were significantly lower compared with the cisplatin regimens (42% v 67%, respectively; P < .001). The relative hazard (RH) of first progression or death was significantly greater among those randomized to paclitaxel (RH = 1.41; 95% confidence interval [CI], 1.15 to 1.73; P < .001) when compared with cisplatin; however, RH did not differ significantly between the two cisplatin regimens (RH = 1.06; 95% CI, 0.895 to 1.30). Relative to cisplatin, the death rate on paclitaxel was 15% greater (RH = 1.15; 95% CI, 0.929 to 1.42), and the death rate on the combination treatment was 1% less (RH = 0.99; 95% CI, 0.795 to 1.23). These differences among treatment groups were not statistically significant (P = .31). CONCLUSION: Cisplatin alone or in combination yielded superior response rates and PFS relative to paclitaxel. However, OS was similar in all three arms, and the combination therapy had a better toxicity profile. Therefore, the combination of cisplatin and paclitaxel remains the preferred initial treatment option.

Consolidation therapy revisited: intravenous chemotherapy

2003 ◽  
Vol 13 (Suppl 2) ◽  
pp. 204-207 ◽  
Author(s):  
M. Markman
Keyword(s):  
Ovarian Cancer ◽  
Gynecologic Oncology ◽  
Single Agent ◽  
Progression Free Survival ◽  
Gynecologic Oncology Group ◽  
Consolidation Therapy ◽  
Oncology Group ◽  
Intravenous Chemotherapy ◽  
Free Survival ◽  
Cumulative Toxicity

The administration of ‘consolidation’ therapy is designed to maximize the benefits achieved from primary chemotherapy, to both improve progression-free and overall survival. Paclitaxel is an excellent agent to consider for a consolidation strategy in ovarian cancer, based on its activity in the disease, its cycle-specificity, and the lack of serious cumulative toxicity (except for neuropathy). A recently reported randomized trial conducted by the South-west Oncology Group and the Gynecologic Oncology Group revealed that 12-monthly cycles of single-agent paclitaxel (175 mg/m2 over 3 h) improves progression-free survival (PFS), compared to 3-monthly cycles of the agent (median PFS: 28 months versus 21 months, P = 0.0023, and hazard ratio 2.31). Further exploration of consolidation/maintenance therapy in the management of ovarian cancer is indicated, focusing on agents that are easy to administer (eg, oral) and that result in limited cumulative toxicity.

Phase III Randomized Trial of Intravenous Cisplatin Plus a 24- or 96-Hour Infusion of Paclitaxel in Epithelial Ovarian Cancer: A Gynecologic Oncology Group Study

2007 ◽  
Vol 25 (28) ◽  
pp. 4466-4471 ◽  
Author(s):  
David R. Spriggs ◽  
Mark F. Brady ◽  
Luis Vaccarello ◽  
Daniel L. Clarke-Pearson ◽  
Robert A. Burger ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Peritoneal Cancer ◽  
Results Of Treatment ◽  
Grade 3 ◽  
To Receive

Purpose This study was undertaken to assess if prolonged paclitaxel administration in combination with cisplatin improves overall survival (OS) in epithelial ovarian cancer (EOC). Patients and Methods Eligible patients with suboptimal stage III or IV EOC, fallopian tube, or primary peritoneal cancer were randomly allocated to receive six cycles of cisplatin 75 mg/m2 and either paclitaxel 135 mg/m2 during 24 hours (arm 1) or paclitaxel 120 mg/m2 during 96 hours (arm 2). Results Planned accrual was 324 patients; 293 were enrolled before the study was closed as a result of a scheduled interim futility analysis. There were 13 ineligible patients; thus, 140 patients in each arm were assessable. In arm 1, 80% of patients completed all six cycles compared with 83% of patients in arm 2. Grade 4 granulocytopenia was more common in arm 1 (79% v 54%; P < .001) whereas grade 3 or worse anemia was more severe in arm 2 (6% v 18%; P < .003). The median progression-free survival was 1.03 years for arm 1 versus 1.05 years for arm 2. The median OS was 2.49 and 2.54 years for arms 1 and 2, respectively. There have been 237 reported deaths. The relative death rate was approximately 12% greater in arm 2 (hazard ratio, 1.12; 95% CI, 0.860 to 1.45). Conclusion Patients with advanced EOC have a relatively poor prognosis. The results of treatment with cisplatin and paclitaxel are not significantly improved by prolonging the paclitaxel infusion from 24 to 96 hours.

Does Severe Anemia Caused by Dose-Dense Paclitaxel-Carboplatin Combination Therapy Have an Effect on the Survival of Patients With Epithelial Ovarian Cancer? Retrospective Analysis of the Japanese Gynecologic Oncology Group 3016 Trial

2011 ◽  
Vol 21 (9) ◽  
pp. 1585-1591 ◽  
Author(s):  
Seisuke Kumagai ◽  
Toru Sugiyama ◽  
Tadahiro Shoji ◽  
Hirofumi Michimae ◽  
Noriyuki Katsumata ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Gynecologic Oncology Group ◽  
Severe Anemia ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Grade 3 ◽  
Dose Dense

IntroductionTo evaluate the incidence of anemia in patients with epithelial ovarian cancer receiving paclitaxel-carboplatin combination therapy (TC) using data from the Japanese Gynecologic Oncology Group (JGOG) 3016 trial, and to examine the effect of severe anemia on survival during dose-dense TC.MethodsRetrospective analysis was conducted in patients enrolled in the JGOG 3016 trial who underwent at least one cycle of the protocol therapy (n = 622). Hemoglobin values at enrollment and during each cycle of TC were collected. One-to-one matching was performed between patients with and patients without grade 3/4 anemia during TC (anemia and nonanemia groups) to adjust the baseline characteristics of the patients. The cumulative survival curve and median progression-free survival were estimated using the Kaplan-Meier method.ResultsGrades 2 to 4 anemia was observed in 19.8% of patients before first-line TC. The incidence of grade 3/4 anemia rapidly increased to 56.1% after the fourth cycle of dose-dense TC. After matching, the median progression-free survival in the anemia (hemoglobin <8.0 g/dL) and nonanemia (hemoglobin >8.0 g/dL) groups was 777 and 1100 days, respectively (P = 0.3493) for patients receiving dose-dense TC. The median progression-free survival in patients receiving conventional TC was similar between the 2 groups.ConclusionsThe difference in progression-free survival between patients with epithelial ovarian cancer with and those without severe anemia during TC was not statistically significant, but for patients receiving dose-dense TC, severe anemia seems to have prognostic relevance. Prospective trials are needed to investigate whether the optimal management of chemotherapy-induced anemia, including appropriate use of erythropoiesis-stimulating agents, would further improve the survival of patients with ovarian cancer receiving dose-dense TC.

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