Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer

Vergote, Ignace; Bois, Andreas du; Floquet, Anne; Rau, Joern; Kim, J.-W.; Campo, J. M. Del; Friedlander, Michael; Pignata, Sandro; Fujiwara, Keiichi; Colombo, Nicoletta; Mirza, Mansoor Raza; Monk, Bradley J.; Tsibulak, I; Calvert, Paula; Herzog, Thomas J.; Hanker, Lars; Meunier, Jérôme; Lee, Jun-Yeop; Bologna, Alessandra; Carrasco-Alfonso, Marlene J.; Harter, Philipp

doi:10.1016/j.ygyno.2019.08.024

Cited by 58 publications

(42 citation statements)

References 25 publications

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“…In addition, the changed delivery route or warm-up of chemotherapy agents (IP administration or IP hyperthermia therapy) has been also accepted in the certain clinical situations [43,44,[70][71][72][73][74][75]. Moreover, advancing drug development, including poly(adenosine diphosphate (ADP)-ribose) polymerase inhibitors (PARPi) as well as small molecules targeting various kinds of signaling pathway has shown the dramatic improvement in ETOC and PPSC treatment [76][77][78][79][80][81][82][83][84][85][86][87]. Finally, immune checkpoint inhibitors or immune system modulators has also provided a chance for ETOC and PPSC patients, although the therapeutic effect is debated [88,89].…”

Section: Current Standard Of Treatmentmentioning

confidence: 99%

Comparing Paclitaxel–Carboplatin with Paclitaxel–Cisplatin as the Front-Line Chemotherapy for Patients with FIGO IIIC Serous-Type Tubo-Ovarian Cancer

Huang

Chen

Lee

et al. 2020

IJERPH

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The use of weekly chemotherapy for the treatment of patients with advanced-stage serous-type epithelial Tubo-ovarian cancer (ETOC), and primary peritoneal serous carcinoma (PPSC) is acceptable as the front-line postoperative chemotherapy after primary cytoreductive surgery (PCS). The main component of dose-dense chemotherapy is weekly paclitaxel (80 mg/m2), but it would be interesting to know what is the difference between combination of triweekly cisplatin (20 mg/m2) or triweekly carboplatin (carboplatin area under the curve 5-7 mg/mL per min [AUC 5-7]) in the dose-dense paclitaxel regimen. Therefore, we compared the outcomes of women with Gynecology and Obstetrics (FIGO) stage IIIC ETOC and PPSC treated with PCS and a subsequent combination of dose-dense weekly paclitaxel and triweekly cisplatin (paclitaxel–cisplatin) or triweekly carboplatin using AUC 5 (paclitaxel–carboplatin). Between January 2010 and December 2016, 40 women with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC EOC, FTC, or PPSC were enrolled, including 18 treated with paclitaxel–cisplatin and the remaining 22 treated with paclitaxel–carboplatin. There were no statistically significant differences in disease characteristics of patients between two groups. Outcomes in paclitaxel–cisplatin group seemed to be little better than those in paclitaxel–carboplatin (median progression-free survival [PFS] 30 versus 25 months as well as median overall survival [OS] 58.5 versus 55.0 months); however, neither reached a statistically significant difference. In terms of adverse events (AEs), patients in paclitaxel–carboplatin group had more AEs, with a higher risk of neutropenia and grade 3/4 neutropenia, and the need for a longer period to complete the front-line chemotherapy, and the latter was associated with worse outcome for patients. We found that a period between the first-time chemotherapy to the last dose (6 cycles) of chemotherapy >21 weeks was associated with a worse prognosis in patients compared to that ≤21 weeks, with hazard ratio (HR) of 81.24 for PFS and 9.57 for OS. As predicted, suboptimal debulking surgery (>1 cm) also contributed to a worse outcome than optimal debulking surgery (≤1 cm) with HR of 14.38 for PFS and 11.83 for OS. Based on the aforementioned findings, both regimens were feasible and effective, but maximal efforts should be made to achieve optimal debulking surgery and following the on-schedule administration of dose-dense weekly paclitaxel plus triweekly platinum compounds. Randomized trials validating the findings are warranted.

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Section: Current Standard Of Treatmentmentioning

confidence: 99%

Comparing Paclitaxel–Carboplatin with Paclitaxel–Cisplatin as the Front-Line Chemotherapy for Patients with FIGO IIIC Serous-Type Tubo-Ovarian Cancer

Huang

Chen

Lee

et al. 2020

IJERPH

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“…Moreover, it was even longer than in results from the experimental and control arms of many studies [57] that have attempted to add another agent to standard chemotherapy, regardless of whether the agents were given simultaneously during front-line chemotherapy or during maintenance therapy after standard chemotherapy [10,11,12,57,58,59,60,61,62,63,64,65]. These adding agents have included antiangiogenic drugs, PARP inhibitors, immune system modulators, and many multitarget compounds that were used as upfront therapy [10,11,12,23,27,28,29,30,31,32,57,58,59,60,61,62,63,64,65].…”

Section: Discussionmentioning

confidence: 99%

Weekly Dose-Dense Paclitaxel and Triweekly Low-Dose Cisplatin: A Well-Tolerated and Effective Chemotherapeutic Regimen for First-Line Treatment of Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Chen

Lee

Chang

et al. 2019

IJERPH

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A combination of cytoreductive surgery, either primary (PCS) or interval (ICS), and chemotherapy with a platinum-paclitaxel regimen is the well-accepted treatment for advanced-stage epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), and primary peritoneal serous carcinoma (PPSC), but it is still uncertain whether a combination of dose-dense weekly paclitaxel and low-dose triweekly cisplatin is useful in the management of these patients. Therefore, we retrospectively evaluated the outcomes of women with advanced-stage EOC, FTC, and PPSC treated with PCS and subsequent dose-dense weekly paclitaxel (80 mg/m2) and low-dose triweekly cisplatin (20 mg/m2). Between January 2011 and December 2017, 32 women with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC–IV EOC, FTC, or PPSC were enrolled. Optimal PCS was achieved in 63.5% of patients. The mean and median progression-free survival was 36.5 and 27.0 months, respectively (95% confidence interval (CI): 26.8–46.2 and 11.3–42.7 months, respectively). The mean overall survival was 56.0 months (95% CI: 43.9–68.1 months), and the median overall survival could not be obtained. The most common all-grade adverse events (AEs) were anemia (96.9%), neutropenia (50%), peripheral neuropathy (28.1%), nausea and vomiting (34.4%), and thrombocytopenia (15.6%). These AEs were predominantly grade 1/2, and only a few patients were complicated by grade 3/4 neutropenia (21.9%) and anemia (6.3%). A multivariate analysis indicated that only suboptimal PCS was significantly correlated with a worse prognosis, resulting in an 11.6-fold increase in the odds of disease progression. In conclusion, our data suggest that dose-dense weekly paclitaxel (80 mg/m2) combined with low-dose triweekly cisplatin (20 mg/m2) is a potentially effective and highly tolerable front-line treatment in advanced EOC, FTC, and PPSC. Randomized trials comparing the outcome of this regimen to other standard therapies for FIGO stage IIIC–IV EOC, FTC, and PPSC are warranted.

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“…Key evidence: The evidence certainty was moderate for the AGO-OVAR16 trial [14,17,21,41] and low for the East Asian Study [23]. In the AGO-OVAR16 trial, at median 24.3 months, pazopanib resulted in greater PFS, but no benefit for final OS analysis at seven years.…”

Section: Recommendation 5 (Strength: Weak Recommendation)mentioning

confidence: 99%

An Ontario Health (Cancer Care Ontario) Clinical Practice Guideline: Consolidation or Maintenance Systemic Therapy for Newly Diagnosed Stage II, III, or IV Epithelial Ovary, Fallopian Tube, or Primary Peritoneal Carcinoma

et al. 2021

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Objective: To provide recommendations on systemic therapy options in consolidation or maintenance therapy for women with newly diagnosed stage II, III, or IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma including all histological types. Methods: Consistent with the Program in Evidence-based Program’s standardized approach, MEDLINE, EMBASE, PubMed, Cochrane Library, and PROSPERO (the international prospective register of systematic reviews) databases, and four relevant conferences were systematically searched. The Working Group drafted recommendations and revised them based on the comments from internal and external reviewers. Results: We have one recommendation for consolidation therapy and eight recommendations for maintenance therapy. Overall, consolidation therapy with chemotherapy should not be recommended in the target population. For maintenance therapy, we recommended olaparib (Recommendation), niraparib (Weak Recommendation), veliparib (Weak Recommendation), and bevacizumab (Weak Recommendation) for certain patients with newly diagnosed stage III–IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, respectively. We do not recommend some agents as maintenance therapy in four recommendations. We are unable to specify the patient population by histological types for different maintenance therapy recommendations. When new evidence that can impact the recommendations is available, the recommendations will be updated as soon as possible.

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Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer

Cited by 58 publications

References 25 publications

Comparing Paclitaxel–Carboplatin with Paclitaxel–Cisplatin as the Front-Line Chemotherapy for Patients with FIGO IIIC Serous-Type Tubo-Ovarian Cancer

Comparing Paclitaxel–Carboplatin with Paclitaxel–Cisplatin as the Front-Line Chemotherapy for Patients with FIGO IIIC Serous-Type Tubo-Ovarian Cancer

Weekly Dose-Dense Paclitaxel and Triweekly Low-Dose Cisplatin: A Well-Tolerated and Effective Chemotherapeutic Regimen for First-Line Treatment of Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

An Ontario Health (Cancer Care Ontario) Clinical Practice Guideline: Consolidation or Maintenance Systemic Therapy for Newly Diagnosed Stage II, III, or IV Epithelial Ovary, Fallopian Tube, or Primary Peritoneal Carcinoma

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