Efficacy and safety of bevacizumab-containing neoadjuvant therapy followed by interval debulking surgery in advanced ovarian cancer: Results from the ANTHALYA trial

Rouzier, Roman; Gouy, Sébastien; Selle, Frédèric; Lambaudie, Éric; Floquet, Anne; Fourchotte, Virginie; Pomel, Christophe; Colombo, Pierre‐Emmanuel; Kalbacher, Elsa; Martin-Françoise, S.; Fauvet, R.; Follana, Philippe; Lesoin, A.; Lécuru, Fabrice; Ghazi, Y.; Dupin, J.; Chéreau, E.; Zohar, Sarah; Cottu, Paul; Joly, Florence

doi:10.1016/j.ejca.2016.09.036

Cited by 92 publications

(54 citation statements)

References 10 publications

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“…In several clinical studies of laparoscopic evaluation or surgery, the number of sites to be evaluated by laparoscopy is small [32]. In other reports of laparoscopic evaluations before IDS, complete resection was achieved in only 51%-58% of patients who were judged to not have unresectable tumors by laparoscopy [33]. These results suggest that it is difficult to identify all disseminated tumors throughout the abdominal cavity.…”

Section: Discussionmentioning

confidence: 97%

Microscopic diseases remain in initial disseminated sites after neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and primary peritoneal cancer

et al. 2020

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Objective: This study aimed to evaluate the presence of pathological residual tumor (pRT) in each initial disseminated site after neoadjuvant chemotherapy (NACT) to assess the appropriate surgical margins during interval debulking surgery (IDS) for a favorable prognosis. Methods: This prospective descriptive study included patients with stage IIIC-IV epithelial ovarian, fallopian tubal, and peritoneal cancer. One hundred eleven patients underwent diagnostic exploratory laparotomy, and their initial intra-abdominal dissemination statuses were recorded. Any tumor >1 cm in diameter found during the exploratory laparotomy was resected during IDS even if it was macroscopically invisible after NACT. The pRT rate after NACT and negative predictive value (NPV; probability that sites with macroscopically invisible tumors have no pRT) during IDS were assessed in each disseminated site. Results: A median of 5 NACT cycles were performed. Sites with a high incidence of pRT and low NPV included the rectosigmoid colon (71.4%, 38.6%), transverse mesentery (70.3%, 50.0%), greater omentum (68.3%, 51.7%), right diaphragm (61.9%, 48.1%), paracolic gutters (61.1%, 50.0%), and vesicouterine pouch (56.6%, 50.0%). Organs/tissues with a high incidence of pRT featured a low NPV. The median progression-free survival and overall survival in this cohort were 27.7 and 71.9 months, respectively. Conclusion: Even if a disseminated site >1 cm in diameter before NACT is invisible during IDS, microscopic disease remains present within it. The appropriate surgical margins for IDS with a favorable prognosis could be secured by resecting a lesion of >1 cm before NACT even if it is invisible during IDS.

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Section: Discussionmentioning

confidence: 97%

Microscopic diseases remain in initial disseminated sites after neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and primary peritoneal cancer

et al. 2020

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“…More recently, results from the French multi-center non-comparative randomized phase II ANTHALYA trial were published 22. In ANTHALYA, patients with stage IIIC or IV ovarian cancer were randomized 2:1 to receive four cycles of neoadjuvant carboplatin and paclitaxel either alone or with bevacizumab during cycles 1–3 before interval debulking surgery.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety results from GEICO 1205, a randomized phase II trial of neoadjuvant chemotherapy with or without bevacizumab for advanced epithelial ovarian cancer

García

Ferré

Mendiola

et al. 2019

Int J Gynecol Cancer

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BackgroundBevacizumab is an approved treatment after primary debulking surgery for ovarian cancer. However, there is limited information on bevacizumab added to neoadjuvant chemotherapy before interval debulking surgery.ObjectiveTo evaluate neoadjuvant bevacizumab in a randomized phase II trial.MethodsPatients with newly diagnosed stage III/IV high-grade serous/endometrioid ovarian cancer were randomized to receive four cycles of neoadjuvant chemotherapy with or without ≥3 cycles of bevacizumab 15 mg/kg every 3 weeks. After interval debulking surgery, all patients received post-operative chemotherapy (three cycles) and bevacizumab for 15 months. The primary end point was complete macroscopic response rate at interval debulking surgery.ResultsOf 68 patients randomized, 64 completed four neoadjuvant cycles; 22 of 33 (67%) in the chemotherapy-alone arm and 31 of 35 (89%) in the bevacizumab arm (p=0.029) underwent surgery. The complete macroscopic response rate did not differ between treatment arms in either the intention-to-treat population of 68 patients (6.1% vs 5.7%, respectively; p=0.25) or the 55 patients who underwent surgery (8.3% vs 6.5%; p=1.00). There was no difference in complete cytoreduction rate or progression-free survival between the treatment arms. During neoadjuvant therapy, grade ≥3 adverse events were more common with chemotherapy alone than with bevacizumab (61% vs 29%, respectively; p=0.008). Intestinal (sub)occlusion, fatigue/asthenia, abdominal infection, and thrombocytopenia were less frequent with bevacizumab. The incidence of grade ≥3 adverse events was 9% in the control arm versus 16% in the experimental arm in the month after surgery.ConclusionsAdding three to four pre-operative cycles of bevacizumab to neoadjuvant chemotherapy for unresectable disease did not improve the complete macroscopic response rate or surgical outcome, but improved surgical operability without increasing toxicity. These results support the early integration of bevacizumab in carefully selected high-risk patients requiring neoadjuvant chemotherapy for initially unresectable ovarian cancer.

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“…23,24 Indeed, major risks related to surgery, such as surgical wound infection and/or dehiscence, pelvic abscess, intestinal subocclusion, and fistula (previously reported in around 28% of the cases) can be avoided by waiting at least 4 weeks before proceeding to surgery. 20 As radical surgery in CC is completely different from large ovarian cytoreductions, it comes with a different spectrum of complications. Indeed, although the former mainly works in the deep pelvis and lymph nodes, the latter is a multivisceralbut-superficial surgery.…”

Section: Discussionmentioning

confidence: 99%

Radical Surgery in Advanced Cervical Cancer Patients Receiving Bevacizumab-Containing Chemotherapy: A “Real Life Experience”

Fagotti

Conte

Stollagli

et al. 2018

Int J Gynecol Cancer

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Efficacy and safety of bevacizumab-containing neoadjuvant therapy followed by interval debulking surgery in advanced ovarian cancer: Results from the ANTHALYA trial

Cited by 92 publications

References 10 publications

Microscopic diseases remain in initial disseminated sites after neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and primary peritoneal cancer

Microscopic diseases remain in initial disseminated sites after neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and primary peritoneal cancer

Efficacy and safety results from GEICO 1205, a randomized phase II trial of neoadjuvant chemotherapy with or without bevacizumab for advanced epithelial ovarian cancer

Radical Surgery in Advanced Cervical Cancer Patients Receiving Bevacizumab-Containing Chemotherapy: A “Real Life Experience”

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