29 mei 2017: ASCO 2017. Met dank aan Linda die me wees op deze studie

Wanneer eierstokkankerpatiënten met gevorderde ziekte (stadium III) na drie chemokuren nog steeds stabiele ziekte laten zien en daarna een debulking operatie krijgen in combinatie met een hypec behandeling (hyperthermic intraperitoneal chemotherapy) dan stijgt de mediane ziektevrije tijd en overall overleving. Dit blijkt uit een 9-jarige Nederlandse studie bij totaal 245 patienten met eierstokkanker stadium III.

In vergelijking met alleen een debulking operatie maar zonder hypec behandeling bleek op de datum dat de studie werd geanalyseerd ( na 9 jaar follow-up) de ziektevrije tijd voor de Hypecgroep 15 maanden versus 11 maanden voor de controlegroep; hazard ratio , 0.65; 95% confidence interval , 0.49 to 0.86; P=0.003).

De overall overleving steeg met 12 maanden:  (48 vs. 34 maanden; HR, 0.64; 95% CI, 0.45 to 0.91, P=0.01) Op moment van de analyse was nog 45 procent van alle deelnemende patienten in leven. Het bijwerkingenprofiel lag nagenoeg gelijk bij beide groepen: (28% vs. 24%, p=0.61).

Deze studie wordt gepresenteerd op 3 juni op ASCO 2017.

Hier alvast het abstract van de studie:

The addition of HIPEC to interval cytoreductive surgery is well tolerated and improves recurrence free and overall survival in patients with stage III epithelial ovarian cancer.

A phase 3 trial of hyperthermic intraperitoneal chemotherapy (HIPEC) for ovarian cancer.

Sub-category:
Ovarian Cancer

Category:
Gynecologic Cancer

Meeting:
2017 ASCO Annual Meeting

Abstract No:
5519

Poster Board Number:
Poster Discussion Session (Board #341)

Citation:
J Clin Oncol 35, 2017 (suppl; abstr 5519)

Author(s): Willemien Van Driel, Karolina Sikorska, Jules Schagen van Leeuwen, Henk Schreuder, Ralph Hermans, Ignace de Hingh, Jacobus Van Der Velden, Henriëtte J.G. Arts, Massuger Leon, Arend Aalbers, Verwaal Victor J., Koen van der Vijver, Neil K Aaronson, Gabe S. Sonke; Center for Gynecologic Oncology, Amsterdam, Netherlands; Netherlands Cancer Institute, Amsterdam, Netherlands; Sint-Antonius Hospital, Nieuwegein, Netherlands; UMC Utrecht Cancer Center, Utrecht, Netherlands; Catharina Hospital, Eindhoven, Netherlands; Department of Gynaecology, University Medical Center Groningen, Groningen, Netherlands; Radboud University Medical Center, Nijmegen, Netherlands; Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands; Aarhus University Hospital, Aarhus, Denmark; The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands

Abstract Disclosures

Abstract:

Background: Cytoreductive surgery and systemic therapy are essential for newly diagnosed ovarian cancer. We conducted a multicenter phase 3 trial to study whether the addition of intraperitoneal chemotherapy under hyperthermic conditions (HIPEC) to interval cytoreductive surgery would improve outcome among patients receiving neo-adjuvant chemotherapy for stage III epithelial ovarian cancer.

Methods: We randomly assigned patients who showed at least stable disease after three cycles of carboplatin (area under the curve 6) and paclitaxel (175 mg/m2) to receive interval cytoreductive surgery with or without HIPEC using cisplatin (100 mg/m2). Randomization was performed per-operatively and eligible patients had no residual mass greater than 2.5 mm. Three additional cycles of carboplatin and paclitaxel were given post-operatively. The primary endpoint was recurrence-free survival. Overall survival, toxicity, and quality-of-life were key secondary endpoints.

Results: A total of 245 patients were randomly assigned to one of the two treatment strategies. In an intention-to-treat analysis, interval cytoreductive surgery with HIPEC was associated with longer recurrence-free survival than interval cytoreductive surgery alone (15 vs. 11 months, respectively; hazard ratio , 0.65; 95% confidence interval , 0.49 to 0.86; P=0.003). At the time of analysis, 49% of patients were alive, with a significant improvement in overall survival favoring HIPEC (48 vs. 34 months; HR, 0.64; 95% CI, 0.45 to 0.91, P=0.01). The number of patients with grade 3-4 adverse events was similar in both treatment arms (28% vs. 24%, p=0.61). Quality-of-life analysis will follow. Conclusions: The addition of HIPEC to interval cytoreductive surgery is well tolerated and improves recurrence free and overall survival in patients with stage III epithelial ovarian cancer. Clinical trial information: NCT00426257


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