Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial

Bois, Andreas du; Kristensen, Gunnar B.; Ray‐Coquard, Isabelle; Reuß, Alexander; Pignata, Sandro; Colombo, Nicoletta; Denison, Ursula; Vergote, Ignace; Campo, José María Del; Ottevanger, Petronella B.; Heubner, Martin; Minarik, Thomas; Sevin, Emmanuel; Gregorio, Nikolaus de; Bidziński, Mariusz; Pfisterer, Jacobus; Malander, Susanne; Hilpert, Felix; Mirza, Mansoor Raza; Scambia, Giovanni; Meier, W.; Nicoletto, Maria Ornella; Bjørge, Line; Lortholary, Alain; Sailer, Martin Oliver; Michael, Agnieszka; Harter, Philipp

doi:10.1016/s1470-2045(15)00366-6

Cited by 201 publications

(121 citation statements)

References 30 publications

(44 reference statements)

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“…However, this hypothesis was not confirmed by other studies evaluating the impact of adding different angiogenesis targeting compounds to chemotherapy in advanced EOC. Both pazopanib [81] and nintendanib [82] demonstrated a significant increase in PFS in patients with small tumor burden. The PFS benefit of the addition of nintendanib to first-line chemotherapy demonstrated even a more pronounced effect in the non-high-risk subgroup (stage III and residuals ≤ 1 cm or stage II) with 27.1 versus 20.8 months.…”

Section: Targeted Therapymentioning

confidence: 95%

FIGO stage IV epithelial ovarian, fallopian tube and peritoneal cancer revisited

Ataseven

Chiva

Harter

et al. 2016

Gynecologic Oncology

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Section: Targeted Therapymentioning

confidence: 95%

FIGO stage IV epithelial ovarian, fallopian tube and peritoneal cancer revisited

Ataseven

Chiva

Harter

et al. 2016

Gynecologic Oncology

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“…Median progression-free survival was significantly longer in the nintedanib group than in the placebo group (17. Gastrointestinal side effects were significantly higher in the nintedanib group (21% vs. 2%) [38]. So, Nintedanib seems to be a useful agent in anti-angiogenesis, but more data end investigation is required to improvise on tolerability.…”

Section: Nintedanibmentioning

confidence: 93%

Epithelial Ovarian Cancers: On-Target is Better than Near-Target

Ghosh¹,

Bajpai²

2016

Chemotherapy

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Epithelial ovarian cancer is the most common cause of gynecological cancer-related mortality worldwide. The discovery that PARP inhibitors block an essential DNA repair pathway in BRCA mutant cells has revolutionized the management of high-grade ovarian cancers. The cross talk among PARP inhibitors and other molecularly targeted therapies such as anti angiogenic drugs further broadens the scope of these agents. A paradigm shift in the management of ovarian cancer is rapidly emerging, potentiated by a better understanding of the underlying defective molecular pathways/mechanisms. This is providing the opportunity for the clinicians to deliver an effective, yet less toxic and durable treatment to a molecularly selected patient population.

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“…Added nintedanib to conventional carboplatin and paclitaxel regimen significantly improves PFS for chemotherapy-naive patients with advanced ovarian cancer in randomized, placebo-controlled phase III trial, AGO-OVAR 12 [76], in which a total of 1,366 patients with stage IIB-IV ovarian cancer who underwent upfront debulking surgery 2:1 randomly assigned to receive six cycles of carboplatin (AUC 5 or 6) and paclitaxel 175 mg/m 2 with or without 200 mg nintedanib or placebo twice a day on days 2–21 of every 3-week cycle for up to 120 weeks. Nintedanib group (n=911) had a significantly longer PFS than placebo group (17.2 months [95% CI, 16.6 to 19.9] vs. 16.6 months [95% CI, 13.9 to 19.1]; HR, 0.84; 95% CI, 0.72 to 0.98; p=0.024).…”

Section: Targeted Therapy Update In Gynecologic Cancermentioning

confidence: 99%

“…Non-high risk group, which was the same as that of ICON7 [73], was defined as stage III and postoperative residual tumor <1 cm or stage II disease. Considering that the ICON collaborators [73] did not report any significant benefit in the complementary subgroup of non-high-risk patients with FIGO stage up to III and no or minimum macroscopic residual tumor of less than or equal to 1 cm maximum diameter, du Bois et al [76] proposed the possibility of the difference of efficacy patterns between anti-angiogenic tyrosine-kinase inhibitors and antibodies. The most common side effects were gastrointestinal including diarrhea (nintedanib group [grade 3, 21%; grade 4, <1%] vs. placebo group [grade 3 only, 2%]).…”

Section: Targeted Therapy Update In Gynecologic Cancermentioning

confidence: 99%

Major clinical research advances in gynecologic cancer in 2015

Suh

Kim

et al. 2016

J Gynecol Oncol

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In 2015, fourteen topics were selected as major research advances in gynecologic oncology. For ovarian cancer, high-level evidence for annual screening with multimodal strategy which could reduce ovarian cancer deaths was reported. The best preventive strategies with current status of evidence level were also summarized. Final report of chemotherapy or upfront surgery (CHORUS) trial of neoadjuvant chemotherapy in advanced stage ovarian cancer and individualized therapy based on gene characteristics followed. There was no sign of abating in great interest in immunotherapy as well as targeted therapies in various gynecologic cancers. The fifth Ovarian Cancer Consensus Conference which was held in November 7–9 in Tokyo was briefly introduced. For cervical cancer, update of human papillomavirus vaccines regarding two-dose regimen, 9-valent vaccine, and therapeutic vaccine was reviewed. For corpus cancer, the safety concern of power morcellation in presumed fibroids was explored again with regard to age and prevalence of corpus malignancy. Hormone therapy and endometrial cancer risk, trabectedin as an option for leiomyosarcoma, endometrial cancer and Lynch syndrome, and the radiation therapy guidelines were also discussed. In addition, adjuvant therapy in vulvar cancer and the updated of targeted therapy in gynecologic cancer were addressed. For breast cancer, palbociclib in hormone-receptor-positive advanced disease, oncotype DX Recurrence Score in low-risk patients, regional nodal irradiation to internal mammary, supraclavicular, and axillary lymph nodes, and cavity shave margins were summarized as the last topics covered in this review.

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Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial

Cited by 201 publications

References 30 publications

FIGO stage IV epithelial ovarian, fallopian tube and peritoneal cancer revisited

FIGO stage IV epithelial ovarian, fallopian tube and peritoneal cancer revisited

Epithelial Ovarian Cancers: On-Target is Better than Near-Target

Major clinical research advances in gynecologic cancer in 2015

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