BALKAN MCO 2011 - S. Beslija - Controversies in recurrent ovarian cancer: role of CA125, timing, role of surgery and new treatment options of 2nd-line therapy
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BALKAN MCO 2011 - S. Beslija - Controversies in recurrent ovarian cancer: role of CA125, timing, role of surgery and new treatment options of 2nd-line therapy
1. Controversies in recurrent ovarian cancer: CA 125, timing, role of surgery and new treatment options of 2-nd line therapy Semir Beslija, MD, PhD Institu t e of oncology Clinical Center of Sarajevo University
24. Effect of PFI on Response Rate Markman M, et al. J Clin Oncol. 1991;9:1801-1805. Months Response Rate (%) 27% 33% 59% 0 10 20 30 40 50 60 5-12 13-24 > 24 The most widely used clinical surrogate for predicting response to chemotherapy and prognosis, as well as for making treatment recommendations in women with recurrent ovarian cancer, is the treatment-free interval, based on the time to progression after chemotherapy.
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29. Paclitaxel/Platinum vs Conventional Platinum-Based Chemotherapy: PFS Parmar MK, et al. Lancet. 2003;361:2099-2106. Paclitaxel plus platinum Conventional treatment Hazard ratio: 0.76; P = .0004 0 20 40 60 80 100 Time From Randomization (yrs) Progression-Free Survival (%) Patients at risk Paclitaxel plus platinum 392 179 52 25 17 Conventional treatment 410 157 45 17 7 1 2 3 4 0
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32. AGO-OVAR 2.5 (GCIG): Progression-Free Survival Carboplatin (n = 178) Gemcitabine/carboplatin (n = 178) Progression-Free Probability 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 0 6 12 18 24 30 36 42 Months Originally published by the American Society of Clinical Oncology. Pfisterer J, et al. J Clin Oncol. 2006;24:4699-4707. HR: 0.72 (95% CI: 0.58-0.90; P = .0031) Median: 8.6 months (range: 7.9-9.7) Median: 5.8 months (range: 5.2-7.1) Log-rank P = .0038
33. Gemcitabine/Carboplatin vs Carboplatin: OS Proportion Surviving Months Log-rank P = .1349* HR: 0.96 (95% CI: 0.75-1.23) 0.0 0.8 0.2 0.3 0.4 0.5 0.6 0.7 0.9 1.0 0.1 0 6 12 18 60 54 48 42 36 30 24 Median: 18.0 months Median: 17.3 months Carboplatin (n = 178) Gemcitabine/carboplatin (n = 178) *Log-rank, unadjusted. Originally published by the American Society of Clinical Oncology. Pfisterer J, et al. J Clin Oncol. 2006;24:4699-4707.
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48. GOG 126 Series: Cytotoxic Agents (1 prior regimen; TFI < 6 months) 1. Rose PG, et al. J Clin Oncol. 1998;16:405-410. 2. Rose PG, et al. Gynecol Oncol. 2003;88:130-135. 3. Markman M, et al. Gynecol Oncol. 2006;101:436-440. 4. Miller DS, et al. J Clin Oncol. 2008;26(May 20 suppl). Abstract 5524. Study Agent Dose/schedule ORR Common SAEs 126-H [1] Docetaxel 100 mg/m 2 every 3 weeks 22.4% Neutropenia (grade 4, 75%) 126-J [2] Oral etoposide 50 mg/m 2 per day 26.8% Neutropenia (grade 3/4, 45%) 126-N [3] Weekly paclitaxel 80 mg/m 2 per Week 20.9% Neuropathy (grade 2, 21%) 126-Q [4] Pemetrexed 900 mg/m 2 every 3 weeks 21% Neutropenia (grade 3/4, 42%)
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58. GOG 170: Biologic Agents* 1. Schilder RJ, et al. Clin Cancer Res. 2005;11:5539-5548. 2. Burger RA, et al. J Clin Oncol. 2007;25:5165-5171. 3. Schilder RJ, et al. J Clin Oncol. 2008;26:3418-3425. 4. Modesitt SC, et al. Gynecol Oncol. 2008;109:182-186. *1-2 previous regimens; TFI < 12 months or 2 previous platinum regimens and TFI > 12 months. Study Agent Dose/Schedule ORR, % Common SAEs 170-C [1] Gefitinib 500 mg PO daily 4.0 Dermatologic, diarrhea 170-D [2] Bevacizumab 15 mg/m 2 21.0 Gastrointestinal, hypertension, venous thromboembolism 170-E [3] Imatinib mesylate 400 mg PO BID 1.8 Neutropenia, dermatologic, gastrointestinal, pain, electrolyte disturbance 170-G [4] Lapatinib 1500 mg PO daily 16.9 Gastrointestinal, hypertension, proteinuria, pulmonary embolus 170-H [4] Vorinostat 400 mg PO daily 4.0 Neutropenia, constitutional, gastrointestinal
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Editor's Notes
Lots of things prior medical history, genetic makeup, and specific char of tumor. Not always static,
WHAT KIND OF THE RECURRENCE CA WE SEE AT THE PATIENTS WITH OVARIAN CANCER
CA-125, cancer antigen 125; OS, overall survival.
CA-125, cancer antigen 125.
CA-125, cancer antigen 125EORTC, European Organisation for Research and Treatment of Cancer; ULN, upper limit of normal.
EARLY INITIATION OF CHEMOTHERAPY DOES NOT HAVE ANY IMPACT ON SURVIVAL
RCT, randomized controlled trial
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AUC, area under the curve; ECOG, Eastern Cooperative Oncology Group; PFS, progression-free survival; PS, performance score; SWOG, Southwestern Oncology Group.
CONSORT diagram. CD, pegylated liposomal doxorubicin plus carboplatin; CP, carboplatin and paclitaxel; ITT, intention to treat; PFS, progression-free survival. (*) Ineligible because of absence of evidence of ovarian cancer.
2008 the submission was announced of a registration dossier to the European Medicines Agency (EMEA) and the FDA for Yondelis when administered in combination with pegylated liposomal doxorubicin (Doxil, Caelyx) for the treatment of women with relapsed ovarian cancer. In 2011, Johnson&Johnson voluntarily withdrew the submission in the United States following a request by the FDA for an additional Phase III study to be done in support of the submission.[10] OS, overall survival; PFS, progression-free survival; PLD, pegylated liposomal doxorubicin; RR, response rate. extract from the sea squirt Ecteinascidia turbinata superoxide near the DNA strand, resulting in DNA backbone cleavage and cell apoptosis
(A) Analysis of progression-free survival (PFS) by independent radiology assessment of all measurable patients (primary end point). (B) Analysis of PFS for patients with platinum-sensitive disease. (C) Analysis of PFS for patients with platinum-resistant disease. (D) Interim analysis of overall survival (OS). HR, hazard ratio; PLD, pegylated liposomal doxorubicin.