OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer.

Background: The purpose of this multistage, adaptively, designed randomized phase II study was to evaluate the role of intraperitoneal (i.p.) chemotherapy following neoadjuvant chemotherapy (NACT) and optimal debulking surgery in women with epithelial ovarian cancer (EOC). Patients and methods: We carried out a multicenter, two-stage, phase II trial. Eligible patients with stage IIB-IVA EOC treated with platinum-based intravenous (i.v.) NACT followed by optimal (<1 cm) debulking surgery were randomized to one of the three treatment arms: (i) i.v. carboplatin/paclitaxel, (ii) i.p. cisplatin plus i.v./i.p. paclitaxel, or (iii) i.p. carboplatin plus i.v./i.p. paclitaxel. The primary end point was 9-month progressive disease rate (PD9). Secondary end points included progression-free survival (PFS), overall survival (OS), toxicity, and quality of life (QOL). Results: Between 2009 and 2015, 275 patients were randomized; i.p. cisplatin containing arm did not progress beyond the first stage of the study after failing to meet the pre-set superiority rule. The final analysis compared i.v. carboplatin/paclitaxel (n = 101) with i.p. carboplatin, i.v./i.p. paclitaxel (n = 102). The intention to treat PD9 was lower in the i.p. carboplatin arm compared with the i.v. carboplatin arm: 24.5% (95% CI 16.2% to 32.9%) versus 38.6% (95% CI 29.1% to 48.1%) P = 0.065. The study was underpowered to detect differences in PFS: HR PFS 0.82 (95% CI 0.57-1.17); P = 0.27 and OS HR 0.80 (95% CI 0.47-1.35) P = 0.40. The i.p. carboplatin-based regimen was well tolerated with no reduction in QOL or increase in toxicity compared with i.v. administration alone. Conclusion: In women with stage IIIC or IVA EOC treated with NACT and optimal debulking surgery, i.p. carboplatin-based chemotherapy is well tolerated and associated with an improved PD9 compared with i.v. carboplatin-based chemotherapy. Clinical trial number: clinicaltrials.gov, NCT01622543.

The effect of monitoring 'processing style' on post-surgical neuropathic pain in women with breast cancer.

BACKGROUND: Pain is a commonly reported symptom following surgery that is more likely to occur in individuals psychologically distressed prior to surgery. Monitoring processing style, a cognitive tendency to focus on health-related threats, has been associated with increased reporting of somatic symptoms, but no studies have specifically addressed the link between this cognitive style and pain. This prospective clinical study aimed to investigate whether monitoring processing style predicted post-surgical pain in women undergoing breast surgery, controlling for pre-surgical psychological distress. METHODS: Women scheduled to undergo breast cancer surgery (N = 106) completed pre-surgical assessments of monitoring processing style (Miller Behavioral Style Scale) and psychological distress (Depression Anxiety Stress Scales-21). Demographic and medical characteristics were documented. Self-reported neuropathic pain (Neuropathic Pain Scale) was assessed at 3 months post surgery. RESULTS: Post-surgical neuropathic pain levels were low to moderate (M = 19.3, SD = 21.1). Higher pre-surgical monitoring processing style scores significantly predicted higher post-surgical neuropathic pain (ß = 0.23, p = 0.023), over and above psychological stress (ß = 0.22, p = 0.020) and age (ß = -0.25, p = 0.011). CONCLUSIONS: Pre-surgical monitoring processing style was an independent predictor of post-surgical neuropathic pain, even when accounting for pre-surgical psychological distress. Since the reduction of post-surgical pain is a key goal of healthcare, efforts should be made prior to breast cancer surgery to counsel and support individuals with high monitoring processing styles irrespective of their level of distress.