To assess the risk of recurrence in patients with stage I (negative cytology) epithelial ovarian cancer receiving no adjuvant therapy.Between 1976 and 1991, 51 patients with apparent stage I ovarian cancer underwent a comprehensive surgical staging that included: peritoneal cytology, omentectomy, pelvic and para-aortic lumphadenectomy, peritoneal biopsies and either unilateral salpingo-oophorectomy or TAH and BSO.Eleven of 51 patients (22%) were found to have stage II or III disease based on a positive staging laparotomy. Thirty-seven of 40 patients with stage I disease received no further therapy. There was one recurrence (stage 1C - grade 1) in patients with surgical stage 1C while there were no recurrences in patients with either stage 1A or 1B disease.This study concludes that surgical staging in apparent early stage ovarian cancer can identify a group of patients that require surgical therapy alone.
We conducted a retrospective review of 44 patients with metastatic or recurrent endometrial carcinoma treated with cisplatin, doxorubicin, cyclophosphamide, and medroxyprogesterone acetate. Thirty-six women had metastatic disease; eight had recurrent disease. In the metastatic group, 12 women had positive peritoneal cytology as the only criterion for metastatic disease. Grade 1 tumors represented 25%, grade 2, 47.7%, and grade 3, 27.3%. The series was divided into four groups based on disease volume before chemotherapy: positive peritoneal cytology only (N = 12), microscopic (N = 11), macroscopic less than 2 cm (N = 6), and macroscopic greater than 2 cm (N = 15). Fifteen patients had measurable disease and eight (53%) had an objective response. The median survival was 31 months for the whole group. Median survivals were not reached for the positive peritoneal cytology only and the microscopic groups. Median survival for the macroscopic less than 2 cm and greater than 2 cm groups were 15 and 10 months, respectively (P less than .0001). The volume of disease was the most important factor in determining survival as well as the time to progression (P less than .0001). The distribution of grade was similar in all groups (P = .88), and grade did not predict survival (P = .80) or recurrence (P = .87). The significant number of low-grade lesions in our series as well as the importance of positive cytology as a predictor of survival underscore the need for surgical pathologic staging in an effort to identify those patients in need of adjuvant therapy.
Department of Obstetrics, Gynecology, and Reproductive Sciences, Division of Gynecologic Oncology, University of Manitoba Winnipeg, Manitoba, Canada. Eur J Gynaecol Oncol 1996;XVII:200-203
The CALYPSO phase III trial compared CD (carboplatin-pegylated liposomal doxorubicin (PLD)) with CP (carboplatin-paclitaxel) in patients with platinum-sensitive recurrent ovarian cancer (ROC). Overall survival (OS) data are now mature. Women with ROC relapsing >6 months after first- or second-line therapy were randomised to CD or CP for six cycles in this international, open-label, non-inferiority trial. The primary endpoint was progression-free survival. The OS analysis is presented here. A total of 976 patients were randomised (467 to CD and 509 to CP). With a median follow-up of 49 months, no statistically significant difference was observed between arms in OS (hazard ratio=0.99 (95% confidence interval 0.85, 1.16); log-rank P=0.94). Median survival times were 30.7 months (CD) and 33.0 months (CP). No statistically significant difference in OS was observed between arms in predetermined subgroups according to age, body mass index, treatment-free interval, measurable disease, number of lines of prior chemotherapy, or performance status. Post-study cross-over was imbalanced between arms, with a greater proportion of patients randomised to CP receiving post-study PLD (68%) than patients randomised to CD receiving post-study paclitaxel (43%; P<0.001). Carboplatin-PLD led to delayed progression and similar OS compared with carboplatin-paclitaxel in platinum-sensitive ROC.
5565 Background: The preliminary results from the phase III study of carboplatin - PLD (C-D) vs Paclitaxel-Carboplatin (C-P) in patients (pts) with OC in late relapse is presented. While the primary endpoint of the study is PFS, the specific toxicity observed from these 2 regimens is critically important. Methods: From 4/05 to 10/07, 974 pts were recruited. Pts were randomized to either (C-P) ([C] AUC 5 iv d1 + [P] 175 mg/m2 iv d1, q3 wks) or (C-D) ([C] + PLD [D] 30 mg/m2 iv d1 q4 wks) for at least 6 cycles. Results: The data from the first 500 pts (C-D, n=251; C-P, n=249) were analyzed (Table). Median number of cycles received was 6 (1- 14) in two arms. Haematological toxicity contributed to more cycle delays in the CD (21%) than in the CP (14%) arm. Neutropenia & infection rates were similar in both arms. G-CSF was administered more frequently to pts in C-D arm (21%) than in C-P arm (15%). Grade (G) > 2 non-haematological toxicity was more frequent in the C-P arm. There were 104 (76 related) severe adverse events (SAE) in the C-P arm vs. 81 (44 related) in the C-D arm. Conclusions: This planned interim safety analysis on the first 500 patients confirmed different toxicity profiles in the two arms, with less drug-related SAE and less early therapy termination in the C-D arm. TOXICITY % Pts in C-D arm % Pts in C-P arm Anaemia G3–4 13 7 Thrombocytopenia G3–4 18 4 Alopecia G>2 9 85 Neuropathy G>2 3 29 Allergic reactions G>2 6 19 Arthralgia /myalgia G>2 4 20 Hand-foot syndrome G>2 13 2 Mucositis G>2 15 7 Early treatment termination (toxicity related) 6 14 No significant financial relationships to disclose.
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