Clinical trial · Observational
Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension
Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Patients Treated With Bevacizumab Maintenance: A Target Trial Emulation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Antiangiogenic therapies like bevacizumab, have notably improved cancer treatment, including for gynecological cancers, by inhibiting the vascular endothelial growth factor and thus limiting tumor growth. In treating advanced ovarian cancer, bevacizumab has been shown to extend progression-free survival by four months, though it also induces or worsens hypertension in 2 to 19% of patients by affecting vascular nitric oxide production or by capillary rarefaction. This hypertension may result in severe cardiovascular events, necessitating the use of antihypertensive drugs like calcium channel blockers and RAAS inhibitors (angiotensin converting enzyme - ACE - inhibitors mainly), despite some concerns about their effects on VEGF secretion and CA125 levels. Clinical guidelines vary, with some favoring ACE inhibitors while others recommend calcium channel blockers, underlining the need for comparative studies on these drugs' oncological and cardiovascular impacts. To address these issues, this study utilizes an emulated trial approach, leveraging comprehensive data from the French National Health Data System to compare the efficacy of these antihypertensive classes in reducing relapse and improving survival in ovarian cancer patients treated with bevacizumab. The investigators will emulate a target clinical trial to compare the impact of antihypertensive treatments on outcomes of patients with bevacizumab-associated hypertension by ACE inhibitors (arm A) versus calcium channel blockers (CCBs, arm B) on the risk of ovarian cancer withdrawal after surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Bevacizumab | — | UNRESOLVED | — |
| Antiangiogenic-Associated Hypertension | — | UNRESOLVED | — |
| Hypertension | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arm A - angiotensin converting enzyme inhibitors (ACEi) | Drug | — | UNRESOLVED |
| arm B - calcium channel blockers (CCBs) | Drug | — | UNRESOLVED |
| arm R - angiotensin receptor blockers ARB | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Main analysis - antihypertensive therapy with bevacizumab (ACEi or CCBs)
- description
- Adjuvant/maintenance bevacizumab after ovarian cancer debulking surgery with antihypertensive therapy monotherapy. Any patients with bevacizumab treated with monotherapy ACEi (arm A) or CCB (arm B) up to 6 months following debulking surgery
- interventionNames
- Drug: arm A - angiotensin converting enzyme inhibitors (ACEi)
- Drug: arm B - calcium channel blockers (CCBs)
- label
- Complementary group - arm C1 - bevacizumab without antihypertensive therapy
- description
- Patients treated with bevacizumab without initiation of antihypertensive treatment within 6 months following debulking surgery
- label
- Complementary group - arm C2 - standard chemotherapy alone
- description
- Patients who were only treated by standard chemotherapy within 6 months following debulking surgery without bevacizumab
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * women with newly ovarian cancer diagnosis (FIGO III to IV) * age over 18 years old at time of ovarian cancer diagnosis * diagnosed between January 1, 2011 and December 31, 2020 * with debulking ovarian cancer surgery and adjuvant chemotherapy Exclusion Criteria: * not in the "Regime general" "Sécurité Sociale" reimbursement system * without standard chemotherapy protocol (carbotaxol every 3 weeks or weekly) * history of heart failure or heart surgery, cardiovascular infarction or any coronaropathy disease, cerebro-vascular disease, arteriopathy of the lower limb, within the year before ovarian cancer surgery. Patients with history of hypertension without any complications were not excluded. * bevacizumab initiation prior to debulking surgery * combination of antihypertensive classes prior bevaizumab or as the first-line hypertensive therapy of bevacizumab-associated hypertension * antihypertensive monotherapy from other classes than CCBs and ACEi (ARBs, beta-blockers, diuretics etc...) as the anti-hypertensive therapy. Therapy could be initiated before ovarian surgery. Complementary analysis : \- patients treated by ARBs
References
Publications (1)
- DERIVEDJochum F, Dumas E, Salem JE, Ederhy S, Hamy AS, Lecointre L, Laas E, Reyal F, Lecuru F, Akladios C, Gougis P. Impact of Antihypertensive Treatment on Outcomes of Adjuvant Bevacizumab for Ovarian Cancer (IATRO), Results from a Nationwide Emulated Clinical Trial. Clin Pharmacol Ther. 2026 Jan;119(1):198-207. doi: 10.1002/cpt.70067. Epub 2025 Sep 26. PMID 40999916