Platinum-sensitive Recurrent Epithelial Ovarian Cancer Research Articles

Positron emission tomography-laparoscopy based method in the prediction of complete cytoreduction in platinum-sensitive recurrent ovarian cancer.

This study was designed to evaluate the positron emission tomography-laparoscopy-based method in the prediction of complete/optimal cytoreduction in platinum sensitive recurrent epithelial ovarian cancer patients. We analysed 223 consecutive recurrent epithelial ovarian cancer patients. Inclusion criteria were absence of extra-abdominal disease and Eastern Cooperative Oncology Group Performance Status ≤2. Complete and optimal secondary cytoreduction are defined as macroscopic absence or less than 1cm of residual tumor at the end of surgery. Laparoscopy was feasible in 210 of 223 patients (94.2%). Laparoscopy stated 127 (60.5%) possible cytoreductions and 83 (39.5%) systemic chemotherapies. In the same population, AGO score evaluation avowed 150 possible cytoreduction (71.5%) and 60 unresectable women (28.5%). Overall, 115 of 210 patients (54.7%) underwent successful secondary cytoreduction: complete and optimal cytoreduction was obtained in 103 (89.5%) and 12 (10.5%) patients, respectively. Laparoscopy obtained a positive predictive value of 91.3%. Laparoscopy recovered to secondary cytoreduction 13 of 60 patients (21.7%) deemed as not resectable according to AGO score. Forty-eight of 150 AGO score positive patients (32%) were judged nonresectable by laparoscopy. This study confirmed that laparoscopy could be effective for the selection of platinum-sensitive recurrent epithelial ovarian cancer patients suitable for complete cytoreduction.

The combination of gemcitabine and carboplatin shows similar efficacy in the treatment of platinum-resistant and platinum-sensitive recurrent epithelial ovarian cancer patients

The aim of this study was to evaluate progression-free survival, overall survival (OS), response rate (RR), and clinical benefit in recurrent ovarian cancer patients treated with gemcitabine and carboplatin and to compare the outcome among platinum-resistant and platinum-sensitive patients. A retrospective study using the medical records of patients diagnosed and treated for recurrent epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma with gemcitabine and carboplatin from 2005 through 2012 at the Tel Aviv Sourasky Medical Center. The treatment regimen was carboplatin (area under the curve=5) administered on day 1 and gemcitabine 850 mg/m administered on days 1 and 8 in a 21-day cycle. Seventy patients with a median age of 57 years (range: 38-86) were included in the study. Most patients (94.3%) were initially diagnosed with stage III-IV disease and 44.3% had platinum-sensitive disease. Median progression-free survival in platinum-sensitive patients was 6.3 months [95% confidence interval (CI): 4.3-8.3] and 6.3 months (95% CI: 4.6-7.9) in platinum-resistant patients. Median overall survival was 15.8 months (95% CI: 13.6-18.1) in the platinum-sensitive patients and 18.4 months (95% CI: 10.0-27.8) in the platinum-resistant patients. Platinum-sensitive patients had a RR of 43.2% and platinum-resistant patients had a RR of 39.1%. The clinical benefit was 70.5% in platinum-sensitive patients and 65.2% in platinum-resistant patients. Overall treatment had a favorable safety profile. Gemcitabine and carboplatin demonstrate moderate toxicity with similar efficacy in both platinum-sensitive and platinum-resistant epithelial ovarian cancer, suggesting reversal of platinum resistance by gemcitabine.

Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study

BackgroundImprovement in treatment for patients with recurrent ovarian cancer is needed. Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy. Median overall survival is reported between 18 and 35 months. Currently, the role of surgery in recurrent ovarian cancer is not clear. In selective patients a survival benefit up to 62 months is reported for patients undergoing complete secondary cytoreductive surgery. Whether cytoreductive surgery in recurrent platinum-sensitive ovarian cancer is beneficial remains questionable due to the lack of level I-II evidence.Methods/DesignMulticentre randomized controlled trial, including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals. Eligible patients are women, with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who meet the inclusion criteria. Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy. Primary outcome measure is progression free survival. In total 230 patients will be randomized. Data will be analysed according to intention to treat.DiscussionWhere the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far. A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained. Therefore the 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed. We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer.Trial registrationNetherlands Trial Register number: NTR3337.

Conclusion

Future OncologyVol. 9, No. 12s Symposium PaperConclusionJalid SehouliJalid SehouliDepartment of Gynecology, European Competence Center for Ovarian Cancer, Campus Virchow Klinikum, Charité University Hospital, Berlin, Germany. Search for more papers by this authorEmail the corresponding author at sehouli@aol.comPublished Online:6 Nov 2013https://doi.org/10.2217/fon.13.200AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View article"Conclusion." , 9(12s), p. 41Keywords: fully platinum-sensitivemechanism of actionovarian cancerpartially platinum-sensitivepegylated liposomal doxorubicintrabectedinReferences1 Monk BJ, Herzog TJ, Kaye SB et al. Final survival results of the randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer. J. Clin. Oncol.29(Suppl.), Abstract 5046 (2011).Crossref, Medline, Google Scholar2 Aghajanian C, Nycum LR, Goff B, Nguyen H, Husain A, Blank SV. Updated overall survival analysis in OCEANS, a randomized Phase 3 trial of gemcitabine + carboplatin and bevacizumab or placebo followed by bevacizumab or placebo in platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. Presented at: the European Society for Medical Oncology (ESMO). Vienna, Austria, 28 September–2 October 2012.Google ScholarFiguresReferencesRelatedDetails Vol. 9, No. 12s eToC Sign up Follow us on social media for the latest updates Metrics Downloaded 21 times History Published online 6 November 2013 Published in print December 2013 Information© Future Medicine LtdKeywordsfully platinum-sensitivemechanism of actionovarian cancerpartially platinum-sensitivepegylated liposomal doxorubicintrabectedinFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.Editorial assistance was provided by Content Ed Net, with funding from PharmaMar, Madrid, Spain.PDF download

967O - Updated Overall Survival Analysis in Oceans, a Randomized Phase 3 Trial of Gemcitabine (G) + Carboplatin (C) and Bevacizumab (BV) or Placebo (PL) Followed by BV or PL in Platinum-Sensitive Recurrent Epithelial Ovarian (ROC), Primary Peritoneal (PPC), or Fallopian Tube Cancer (FTC)

ABSTRACT Background In OCEANS, BV in combination with GC resulted in a statistically significant and clinically meaningful improvement in PFS in patients (pts) with platinum-sensitive (Plat-S) ROC (median PFS, 12.4 vs 8.4 months; HR = 0.484;P Methods Eligibility criteria included first recurrence of Plat-S OC, PPC, or FTC with an ECOG PS of 0 or 1, no prior BV or chemotherapy for ROC, and measurable disease. Pts were randomized 1:1 to arm A: GC (G [1000 mg/m2, days 1 and 8] and C [AUC 4, day 1], q3w for 6–10 cycles) + concurrent PL (q3w), followed by PL until disease progression (PD) or unacceptable toxicity; or arm B: GC + concurrent BV (15 mg/kg q3w), followed by BV until PD or unacceptable toxicity. The primary end point was investigator-assessed PFS by RECIST. Secondary end points included ORR, OS, DOR, and safety. The 3rd interim OS analysis was conducted with a data cutoff date of March 30, 2012. Results As of the data cutoff date, 286 events (59% of pts) had occurred. There was no difference in OS between the arms, with an HR of 0.960 (95% CI, 0.760–1.214; log-rank P = 0.736). With a median follow-up of 42 months, median OS was 33.7 months in the GC + PL arm and 33.4 months in the GC + BV arm. There was no difference in the number of grade 5 treatment-emergent adverse events between arms (1 in each), the number of deaths was balanced between arms, and the cause of death in the majority of cases was PD in both arms. 89% and 86% of pts received subsequent therapy (including BV in 39% and 22%) in the PL and BV arms, respectively. Conclusions These data provide assurance that there is no detriment to OS with the addition of BV in this setting, and supports the positive benefit:risk ratio of the GC + BV regimen in significantly improving PFS in patients with platinum-sensitive ROC. Disclosure L.R. Nycum: Dr. Nycuum was a member of the Avastin-Ovary advisory board for Genentech for a contract of 1 year. The contract ended the end of March 2012. H. Nguyen: Hoa Nguyen is an employee of Genentech and owns stock in Roche. A. Husain: Dr. Husain is an employee of Genentech and holds stock ownership (Roche). All other authors have declared no conflicts of interest.

The Role of Bevacizumab in Advanced Epithelial Ovarian Cancer

There is a strong rationale for usage of anti-angiogenic agents in epithelial ovarian cancer. Bevacizumab is the most widely investigated anti-VEGF agent and has shown promising results in recent clinical trials. To review the rationale and usage of bevacizumab in advanced epithelial ovarian cancer; as mono-therapy, in combination with chemotherapy both as first line and for recurrent ovarian cancer as well as in combination with other targeted therapies. In epithelial ovarian cancer, angiogenesis promotes tumor growth, ascites formation and metastasis. Targeting VEGF in ovarian cancer patients may have indirect and direct cytotoxic effects. Results of placebo controlled phase III trials, the GOG-218 and ICON7, of carboplatin-paclitaxel alone or combined with bevacizumab in chemo-naive patients and the OCEAN trial comparing carboplatin-gemcitabine with or without bevacizumab in women with recurrent platinum-sensitive epithelial ovarian cancer all suggest a benefit for the addition of bevacizumab on progression free survival. Additionally, bevacizumab in combination with other targeted therapies, such as sorafenib and everolimus are under investigation in phase II trials and the current knowledge of molecular predictors is discussed. Until now no survival benefit has been observed, but bevacizumab is the first anti-angiogenic agent demonstrating a progression free survival benefit in addition to standard chemotherapy regimens in advanced epithelial ovarian cancer, both in the upfront and recurrent setting. Mature overall survival data and the search for predictive biomarkers are important for the future role of bevacizumab in epithelial ovarian cancer.

Phase I safety study of farletuzumab, carboplatin, and pegylated liposomal doxorubicin (PLD) in patients with platinum-sensitive epithelial ovarian cancer (EOC).

5062^ Background: Farletuzumab (FAR) is a humanized monoclonal antibody that binds to folate receptor-α, a target which is largely absent in normal epithelium and over-expressed in EOC. A phase I and a phase II study indicate potential utility of FAR in combination with carboplatin/paclitaxel in recurrent platinum sensitive EOC. This study assessed safety and efficacy of FAR in combination with PLD/carboplatin, which has been demonstrated to have greater efficacy than carboplatin/paclitaxel in women with platinum-sensitive EOC. Methods: A multicenter, single-arm study enrolled 15 patients with platinum-sensitive EOC in first or second relapse defined by either CA-125 or RECIST. The primary endpoint is to assess safety of FAR plus PLD/carboplatin in this population. Patients were treated with weekly FAR 2.5 mg/kg plus carboplatin AUC 4-5 and PLD 30 mg/m2 every 4 weeks for 6 cycles, followed by maintenance treatment with single agent FAR until disease progression. Initial dosing of weekly 2.5 mg/kg was later amended to 7.5 mg/kg every 3 weeks. Results: 13 of 15 patients completed 6 cycles of combination therapy; one received a total of 12 cycles of chemotherapy. Two patients progressed during combination therapy: one received 3 cycles, the other 5 cycles. The median number of subsequent single agent maintenance cycles was 8 (range 0-13). No grade 4 toxicities were observed. Of 20 grade 3 toxicities in 14 patients, 3 (1 fatigue; 2 small bowel obstructions in the same patient) were deemed by the investigator to be possibly related to FAR. These events were seen during the combination phase and were deemed by the investigator to be also possibly related to chemotherapy. All patients demonstrated clinical benefit: 1 complete response, 10 partial response and 4 stable disease. 7 patients have come off study, all for disease progression; a median PFS of 11 months was noted. 8 patients remain on study. Conclusions: These preliminary data indicate that the safety profile of FAR in combination with carboplatin and PLD is consistent with that historically recorded for carboplatin and PLD alone. Complete safety profile will be assessed; PK data and final results will be presented.

Late-Breaking Abstract 5: Results from a 2nd interim OS analysis in OCEANS: A randomized phase 3 trial of gemcitabine (G), carboplatin (C) and bevacizumab (BV) followed by BV to disease progression in patients with platinum-sensitive recurrent epithelial ovarian (OC), primary peritoneal (PPC), or fallopian tube cancer (FTC)

Late-Breaking Abstract 5: Results from a 2nd interim OS analysis in OCEANS: A randomized phase 3 trial of gemcitabine (G), carboplatin (C) and bevacizumab (BV) followed by BV to disease progression in patients with platinum-sensitive recurrent epithelial ovarian (OC), primary peritoneal (PPC), or fallopian tube cancer (FTC)

OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

This randomized, multicenter, blinded, placebo-controlled phase III trial tested the efficacy and safety of bevacizumab (BV) with gemcitabine and carboplatin (GC) compared with GC in platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer (ROC). Patients with platinum-sensitive ROC (recurrence ≥ 6 months after front-line platinum-based therapy) and measurable disease were randomly assigned to GC plus either BV or placebo (PL) for six to 10 cycles. BV or PL, respectively, was then continued until disease progression. The primary end point was progression-free survival (PFS) by RECIST; secondary end points were objective response rate, duration of response (DOR), overall survival, and safety. Overall, 484 patients were randomly assigned. PFS for the BV arm was superior to that for the PL arm (hazard ratio [HR], 0.484; 95% CI, 0.388 to 0.605; log-rank P < .0001); median PFS was 12.4 v 8.4 months, respectively. The objective response rate (78.5% v 57.4%; P < .0001) and DOR (10.4 v 7.4 months; HR, 0.534; 95% CI, 0.408 to 0.698) were significantly improved with the addition of BV. No new safety concerns were noted. Grade 3 or higher hypertension (17.4% v < 1%) and proteinuria (8.5% v < 1%) occurred more frequently in the BV arm. The rates of neutropenia and febrile neutropenia were similar in both arms. Two patients in the BV arm experienced GI perforation after study treatment discontinuation. GC plus BV followed by BV until progression resulted in a statistically significant improvement in PFS compared with GC plus PL in platinum-sensitive ROC.

Best predictors of survival outcome after tertiary cytoreduction in patients with recurrent platinum-sensitive epithelial ovarian cancer

To evaluate the efficacy of tertiary cytoreduction (TCR) on survival and to determine prognostic factors which may influence surgical and survival outcome. Twenty-three consecutive patients who had recurrent platinum-sensitive epithelial ovarian cancer and underwent TCR between January 1999 and January 2011 were evaluated. Factors which impact on TCR outcome and survival were determined by statistical analysis. TCR was optimal (< 1cm residual tumor) in 15 of the 23 patients (65.2%) and suboptimal in 8 patients (34.8%). None of the clinicopathologic factors was associated with TCR outcome. On the contrary, TCR outcome (optimal vs suboptimal) was independently associated with survival in univariate analysis (P=0.018). There is not a good predictor of TCR outcome but TCR seems to be beneficial for patients in whom optimal surgery can be achieved. Therefore, preoperative assessment of patients and weighing the potential survival benefit against potential surgical risks are very important for patient selection.

Intraperitoneal Chemotherapy for Recurrent Epithelial Ovarian Cancer Is Feasible With High Completion Rates, Low Complications, and Acceptable Patient Outcomes

Three large randomized clinical trials have shown a survival benefit for patients treated with intraperitoneal (IP) compared with intravenous chemotherapy for advanced stage epithelial ovarian cancer (EOC). However, the use of IP chemotherapy in recurrent EOC is controversial. The purpose of this study was to determine outcomes, completion rates, and frequency of complications in patients with platinum-sensitive recurrent EOC treated with IP chemotherapy. A retrospective, single-institution analysis of women who received IP chemotherapy for recurrent EOC from January 2003 to April 2010 was conducted. Study patients were identified from the Tumor Registry and office records. Demographic factors, stage, histology, surgical findings, cytoreduction status, and subsequent therapies were abstracted. Progression-free (PFS) and overall survival (OS) were estimated by Kaplan-Meier methods. Fifty-six women who received IP chemotherapy for their first EOC recurrence were identified. The mean age of patients was 56.7 years (range, 40-79 y). Fifty-five patients (98.3%) had previously completed at least 6 cycles of intravenous chemotherapy. Of all patients, 87.5% were initially diagnosed with advanced stage disease (stage IIA-IV). All patients underwent secondary cytoreduction at the time of IP port placement. Moreover, 67.9% of patients were considered optimally cytoreduced (<1 cm residual disease) at the end of the secondary debulking surgery. Forty-two patients (75%) were able to successfully complete at least 6 cycles of IP chemotherapy. Reasons for noncompletion were disease progression, allergic reaction, renal failure, pain, severe nausea and vomiting, death, and patient refusal. Six patients (10.7%) developed port complications including pain around port site, port malfunction, and port erosion into small bowel. Median PFS since the initiation of IP chemotherapy was 10.5 months (95% confidence interval, 7.5-16.4 months) and median OS was 51 months (95% confidence interval, 40.8-61.1 months). Intraperitoneal chemotherapy is a feasible option for patients with recurrent EOC, with high completion rates, low frequency of complications, and acceptable PFS and OS.

OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A multicenter, randomized, phase 2 clinical trial to evaluate the efficacy and safety of combination docetaxel and carboplatin and sequential therapy with docetaxel then carboplatin in patients with recurrent platinum‐sensitive ovarian cancer

The aim of this randomized clinical trial was to evaluate the efficacy and safety of combination (cDC) and sequential (sDC) weekly docetaxel and carboplatin in women with recurrent platinum-sensitive epithelial ovarian cancer (EOC). Participants were randomized to either weekly docetaxel 30 mg/m(2) on days 1 and 8 and carboplatin area under the curve (AUC) = 6 on day 1, every 3 weeks or docetaxel 30 mg/m(2) on days 1 and 8, every 3 weeks for 6 cycles followed by carboplatin AUC = 6 on day 1, every 3 weeks for 6 cycles or until disease progression. The primary endpoint was measurable progression-free survival (PFS). Between January 2004 and March 2007, 150 participants were enrolled. The response rate was 55.4% and 43.2% for those treated with cDC and sDC, respectively. The median PFS was 13.7 months (95% confidence interval [CI], 9.9-16.8) for cDC and 8.4 months (95% CI, 7.1-11.0) for sDC. On the basis of an exploratory analysis, patients treated with sDC were at a 62% increased risk of disease progression compared to those treated with cDC (hazard ratio = 1.62; 95% CI, 1.08-2.45; P = .02). The median overall survival time was similar in both groups (33.2 and 30.1 months, P = .2). The incidence of grade 2 or 3 neurotoxicity and grade 3 or 4 neutropenia was higher with cDC than with sDC (11.7% vs 8.5%; 36.8% vs 11.3%). The sDC group demonstrated significant improvements in the Functional Assessment for Cancer Therapy-Ovarian, Quality of Life Trial Outcome Index scores compared with the combination cohort (P = .013). Both cDC and sDC regimens have activity in recurrent platinum-sensitive EOC with acceptable toxicity profiles. The cDC regimen may provide a PFS advantage over sDC.

Efficacy in Patient Subgroups in OCEANS, a Randomized, Double-blinded, Placebo-controlled, Phase 3 Trial of Chemotherapy ± Bevacizumab in Patients with Platinum-sensitive Recurrent Epithelial Ovarian (OC), Primary Peritoneal (PPC), or Fallopian Tube Cancer (FTC)

Efficacy in Patient Subgroups in OCEANS, a Randomized, Double-blinded, Placebo-controlled, Phase 3 Trial of Chemotherapy ± Bevacizumab in Patients with Platinum-sensitive Recurrent Epithelial Ovarian (OC), Primary Peritoneal (PPC), or Fallopian Tube Cancer (FTC)

OCEANS: A randomized, double-blinded, placebo-controlled phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC).

LBA5007 Background: BEV, a humanized anti-VEGF monoclonal antibody, has shown a progression-free survival (PFS) benefit in 2 frontline phase III trials in patients with EOC, PPC and FTC. The therapeutic impact of BEV in combination with carboplatin (C) and gemcitabine (G) followed by single agent BEV to disease progression (PD) was evaluated in this phase III trial in the platinum-sensitive recurrent setting. Methods: Patients had recurrent, platinum-sensitive EOC, PPC or FTC, 1 prior regimen, no prior BEV, ECOG performance status 0-1, measurable disease. Subjects were randomized to: Arm A: [IV C (AUC 4, Day (D) 1) + G (1,000 mg/m2 D1 and 8) + placebo (PL) D1] q21D x 6 cycles (c) → PL q21D until PD or unacceptable toxicity (tox) Arm B: [CG + BEV (15 mg/kg) D1] q21D x 6 c → BEV q21D until PD or tox primary endpoint was investigator assessed PFS (RECIST). Secondary endpoints included objective response (OR), overall survival (OS), duration of response and safety. The design provided 80% power to detect a 27% reduction in the hazard of progression or death in Arm B vs A, limiting the overall type I error of 5%. Results: OCEANS enrolled 484 patients (242 per arm) from 4/07 - 1/10, median follow up of 24 months. BEV plus CG followed by single agent BEV to PD significantly increased PFS compared to CG alone (HR=0.484, p&lt;0.0001). OR increased by 21% (p&lt;0.0001). OS data is immature with only 29% of patients having had an event. The safety profile was consistent with other BEV trials. Conclusions: Results show a statistically significant and clinically relevant benefit when bevacizumab is added to chemotherapy in patients with recurrent, platinum sensitive EOC, PPC, and FTC. This is the first phase III trial of an antiangiogenic to demonstrate a clinical benefit to these patients. [Table: see text]

OCEANS: A randomized, double-blinded, placebo-controlled phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC).

OCEANS: A randomized, double-blinded, placebo-controlled phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC).

Secondary cytoreductive surgery in the management of platinum‐sensitive recurrent epithelial ovarian cancer

To assess the surgical and survival outcomes after secondary cytoreductive surgery (SCRS) in patients with platinum-sensitive recurrent epithelial ovarian cancer (EOC) and to identify patients who would most benefit from SCRS. Inclusion criteria consisted of (1) recurrent EOC; (2) disease-free interval (DFI) >or=6 months after primary therapy; and (3) SCRS with therapeutic intent followed by adjuvant chemotherapy. Sixty-seven patients met the inclusion criteria in the interval 1992-2008. Median DFI was 20 months (range: 6-109 months). Median time in surgery was 240 min (range: 60-680 min), and median estimated blood loss was 100 ml (range: 50-3,000 ml). There was no significant perioperative complication requiring reoperation. Complete resection of all visible tumor tissue was achieved in 37 patients (55.2%), with residual tumors (RT) <or=1 cm remaining in four patients (6%). After a mean follow-up of 41 months (range: 6-145 months), the 2- and 5-year disease-free survival (DFS) rates were 32% and 10%, respectively, and the 2- and 5-year overall survival (OS) rates were 58% and 26%, respectively. In multivariable analysis, DFI >24 months and RT <or=1 cm were significant predictors of DFS and OS. SCRS is safe and effective, with a low rate of complications. Patients who benefited most from this surgery were those with a DFI >24 months and patients who achieved optimal cytoreduction.

Secondary cytoreductive surgery for recurrent platinum-sensitive ovarian cancer

Objective To determine the risks and benefits of secondary cytoreductive surgery for recurrent platinum-sensitive ovarian cancer. Methods Data were obtained retrospectively for all women with recurrent platinum-sensitive epithelial ovarian cancer who underwent a second debulking operation between 1998 and 2008 at the University of Texas Southwestern Medical Center. Survival analysis and comparisons were performed using the Kaplan-Meier method, log-rank test, and Cox multivariate proportional hazards model. Results Optimal secondary cytoreductive surgery (< 5 mm of residual disease) was achieved in 32 of 40 patients (80%). Nine women (23%) developed major complications. Two variables, residual disease of less than 5 mm vs 5 mm or greater (median 63 months vs 11 months; P = 0.003); and less than 5 vs 5 or more sites of disease relapse (median 63 months vs 22 months; P = 0.009), were independently associated with survival and retained prognostic significance on multivariate analysis. Conclusions Optimal secondary cytoreductive surgery was associated with a survival advantage and acceptable risks.

8032 Cytoreductive surgery (peritonectomy procedures) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of diffuse peritoneal carcinomatosis from ovarian cancer

To determine the risks and benefits of secondary cytoreductive surgery for recurrent platinum-sensitive ovarian cancer.Data were obtained retrospectively for all women with recurrent platinum-sensitive epithelial ovarian cancer who underwent a second debulking operation between 1998 and 2008 at the University of Texas Southwestern Medical Center. Survival analysis and comparisons were performed using the Kaplan-Meier method, log-rank test, and Cox multivariate proportional hazards model.Optimal secondary cytoreductive surgery (< 5 mm of residual disease) was achieved in 32 of 40 patients (80%). Nine women (23%) developed major complications. Two variables, residual disease of less than 5 mm vs 5 mm or greater (median 63 months vs 11 months; P = 0.003); and less than 5 vs 5 or more sites of disease relapse (median 63 months vs 22 months; P = 0.009), were independently associated with survival and retained prognostic significance on multivariate analysis.Optimal secondary cytoreductive surgery was associated with a survival advantage and acceptable risks.