Lecuru 2019.

Study characteristics
Methods	Secondary analysis of the CHIVA double‐blind randomised phase II GINECO study. The CHIVA trial explored the role of nintedanib in combination with NACT vs placebo in combination with NACT.
Participants	N = 163 participants treated with NACT with FIGO stage IIIC to IV AOC considered as unresectable after laparoscopic (lap) evaluation 188 participants were originally enrolled into the trial. The decision to exclude 25 participants was not stated.
Residual disease details	Women were treated with 3 to 4 cycles of platinum‐taxane NACT + oral nintedanib before interval debulking surgery (IDS). CT (up to 6 cycles in total) and nintedanib were pursued postoperatively. No definition of optimal cytoreduction provided. Complete surgical resection response (referred to in study as CC0) included as variable but no explicit definition.
Outcomes	Multivariable Cox PH model adjusted for ECOG, ascites, neutrophil/lymphocyte ratio, PCI at baseline, RECIST ORR, CC0 at IDS, PCR and treatment arm (nintedanib vs placebo): Complete surgical response (CC0) was predictive of both PFS and OS in multivariable Cox PH models (P < 0.01)
Risk of bias (QUIPS)	1. Study participation (a‐f): high risk Abstract only therefore insufficient information on study participation 2. Study attrition (a‐e): unclear risk Unclear if patients with incomplete follow‐up were excluded before arriving at the stated sample size. Insufficient information to permit judgement. 3. Prognostic factor measurement (a‐f): low risk Valid and reliable measurement of RD Outcome level assessment: Outcome: overall survival 4. Outcome measurement (a‐c): low risk Definition of OS not provided but it usually has a standard definition. 5. Adjustment for other prognostic factors (a‐g): high risk Not explicitly stated but implied that model predicting OS adjusted for ECOG, ascites, neutrophil/lymphocyte ratio, Peritoneal Cancer Index at baseline, response rate at end of NACT according to RECIST (RECIST ORR), pathological complete or near complete response rate and treatment arm 6. Statistical analysis and reporting (a‐d): high risk No conceptual framework; variable selection criteria undefined and magnitude of effect not reported, only P value Outcome: progression‐free survival 4. Outcome measurement (a‐c): low risk Definition of PFS not provided but it usually has a standard definition. 5. Adjustment for other prognostic factors (a‐g): high risk Not explicitly stated but implied that model predicting OS adjusted for ECOG, ascites, neutrophil/lymphocyte ratio, Peritoneal Cancer Index at baseline, response rate at end of NACT according to RECIST (RECIST ORR), pathological complete or near complete response rate and treatment arm 6. Statistical analysis and reporting (a‐d): high risk No conceptual framework; variable selection criteria undefined and magnitude of effect not reported, only P value
Notes	Abstract only Refer to Ferron 2019 for trial results for all n = 188 participants From Ferron 2019: Women with FIGO stage IIIC to IV chemotherapy‐naive AEOC considered as unresectable after laparoscopic evaluation were randomised (2:1) to be treated with 3 to 4 cycles (cy) of carboplatin (AUC 5 mg/mL/min) and paclitaxel (175 mg/m²) (CP) before interval debulking surgery (IDS) followed by 2 to 3 cycles of CP for a total of 6 cycles, plus either 200 mg of nintedanib (arm A) or placebo (arm B) twice daily on days 2 to 21 q3 week at cycles 1 and 2, 5 and 6 and maintenance therapy for up to 2 years.