Phase III Randomized Trial of 12 Versus 3 Months of Maintenance Paclitaxel in Patients With Advanced Ovarian Cancer After Complete Response to Platinum and Paclitaxel-Based Chemotherapy: A Southwest Oncology Group and Gynecologic Oncology Group Trial

Markman, Maurie; Liu, P.Y.; Wilczynski, Sharon P.; Monk, Bradley J.; Alvarez, Ronald D.; Jiang, Caroline S.; Alberts, David S.

doi:10.1200/jco.2003.07.013

Cited by 423 publications

(224 citation statements)

References 17 publications

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“…Another clinically useful biomarker might improve postoperative decision-making in several ways. First, the potential for protracted paclitaxel therapy to have a considerable impact on progression of the disease process has recently been demonstrated (16). CA125 alone is not reliable for identifying patients at risk for early relapse who would be most likely to benefit.…”

Section: Discussionmentioning

confidence: 99%

Osteopontin as an Adjunct to CA125 in Detecting Recurrent Ovarian Cancer

Schorge

Drake

Lee

et al. 2004

Clinical Cancer Research

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Purpose: CA125 is currently the only tumor marker to have a validated role in the postoperative monitoring of ovarian cancer. Osteopontin (OPN) is a putative plasma biomarker that was recently identified using high-throughput cDNA microarray technology. The purpose of this study was to test the hypothesis that OPN is a clinically useful adjunct to CA125 in detecting recurrent ovarian cancer.Experimental Design: Thirty-eight ovarian cancer patients had a single pretreatment blood sample and 200 postoperative specimens were prospectively collected during chemotherapy and follow-up. OPN measurements were performed using an enzyme-linked immunoassay, and CA125 levels were concurrently obtained. Wilcoxon's signed ranksum test was used to perform paired comparisons between pretreatment and postoperative OPN and CA125 measurements. Longitudinal mixed effects polynomial models were used to determine whether OPN and CA125 levels correlated with the development of recurrent ovarian cancer. Results:The median pretreatment OPN level was 178 ng/ml (range, 12-3468) and the median CA125 measurement was 812 units/ml (range, 12-81,500). There was a trend for OPN levels to decline after treatment was initiated (P ‫؍‬ 0.07), but decreasing CA125 measurements were more consistently observed (P ‫؍‬ 0.0009). The quadratic functional trends of OPN and CA125 were each highly significant (P < 0.0001). Although inferior to CA125 in predicting clinical response to therapy, OPN rose earlier in 90% (95% confidence interval, 56 -100%) of the patients developing recurrent disease (median lead time, 3 months).Conclusions: OPN may be a clinically useful adjunct to CA125 in detecting recurrent ovarian cancer.

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Section: Discussionmentioning

confidence: 99%

Osteopontin as an Adjunct to CA125 in Detecting Recurrent Ovarian Cancer

Schorge

Drake

Lee

et al. 2004

Clinical Cancer Research

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“…1,2 Factors that are believed to impact survival include patient age, performance status, preoperative CA125, volume of ascites, stage, grade, extent of cytoreductive surgery, chemotherapeutic agents, route of delivery, duration of treatment, histological subtype, host immune response, and specific genetic alterations, including BRCA mutations. [2][3][4][5][6][7][8][9][10][11][12][13][14][15] There remains, however, limited ability to accurately prognosticate in patients with advanced stage high-grade serous carcinoma based on features of the primary tumor at the time of diagnosis.…”

mentioning

confidence: 99%

BRCA1 and BRCA2 mutations correlate with TP53 abnormalities and presence of immune cell infiltrates in ovarian high-grade serous carcinoma

et al. 2012

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We characterized BRCA1 and BRCA2 status (mutation/methylation) in a consecutive series of cases of ovarian carcinoma in order to identify differences in clinicopathological features, molecular characteristics, and outcome between the pelvic high-grade serous cancers with (i) germline or somatic mutations in BRCA1 or BRCA2, (ii) methylation of BRCA1, and (iii) normal BRCA1 or BRCA2. In all, 131 women were identified prospectively, who were undergoing surgical staging and agreed to germline testing for BRCA1 and BRCA2 mutations. Histopathology, germline and somatic BRCA1 or BRCA2 mutations, BRCA1 methylation, and BRCA1 and BRCA2 mRNA expression levels distinguished four subgroups. In all, 103 cases were high-grade serous carcinoma and of these 31 (30%) had germline or somatic BRCA1 or BRCA2 mutations (20% BRCA1 and 10% BRCA2) (group 1), 21 (20%) had methylation of BRCA1 (group 2), and in 51 (50%) there was no BRCA loss (group 3). Group 4 consisted of 28 cases of non-high-grade serous, none of which had BRCA loss. BRCA1 and BRCA2 mRNA expression levels correlated with designated group (P ¼ 0.0008). Among high-grade serous carcinomas, there were no differences between groups 1-3 with respect to stage, ascites, CA125 level, platinum sensitivity, cytoreduction rate, neoadjuvant chemotherapy, or survival. Tumors with BRCA1 or BRCA2 mutations had increased immune infiltrates (CD20 and TIA-1) compared with high-grade serous without mutations (P ¼ 0.034, 0.027). TP53 expression differed between groups (Po0.0001), with abnormal TP53 expression in 49/50 tumors from groups 1 and 2. Wild-type TP53 expression was associated with worse outcome in high-grade serous (Po0.001). BRCA loss (mutation/methylation) is a common event in the pelvic high-grade serous (50%). TP53 abnormalities and increased immune cell infiltrates are significantly more common in high-grade serous with germline and somatic mutations in BRCA1 or BRCA2, compared with tumors lacking BRCA abnormalities.

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“…34 A large SWOG/GOG intergroup study with paclitaxel as consolidation therapy in patients with advanced ovarian cancer reported a median PFS of 21 and 28 months in the 3-and 12-cycle arms, respectively. 35 These data suggest that a brief course of i.p. topotecan may be comparable to other consolidation treatment options for advanced ovarian cancer.…”

Section: Discussionmentioning

confidence: 91%

Phase 2 study of intraperitoneal topotecan as consolidation chemotherapy in ovarian and primary peritoneal carcinoma

Muntz

Malpass

McGonigle

et al. 2008

Cancer

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BACKGROUND.Intravenous topotecan is approved for the treatment of ovarian cancer (OC). In intraperitoneal (i.p.) topotecan studies, 20 mg/m2 dosing was tolerable. This study evaluated the feasibility, safety, and preliminary efficacy of i.p. topotecan as consolidation chemotherapy in patients with OC or primary peritoneal cancers (PPCs).METHODS.Patients with stage III/IV ovarian or PPC in clinical complete response after surgical cytoreduction and intravenous carboplatin/paclitaxel chemotherapy who had benign findings or minimal persistent disease (≤1 cm diameter) at second‐look surgery were eligible. Intraperitoneal topotecan 20 mg/m2 was infused once every 21 days for 4 to 6 cycles. Kaplan‐Meier estimates were used to calculate progression‐free survival (PFS) and overall survival (OS).RESULTS.Twenty patients were enrolled (18 [90%] patients had OC). Sixteen patients received 4 cycles, 3 patients received 6 cycles, and 1 patient withdrew after 1 cycle. The mean delivered dose was 18 mg/m2. Grade 3/4 toxicities included neutropenia and thrombocytopenia (45% for both). Grade 1/2 abdominal distension and nausea were reported in 60% and 40% of patients, respectively. Median PFS was 24 months from second‐look surgery (95% confidence intervals [CI]: ±10 months). Sixteen patients were alive and median OS was not reached at the time of data analysis. OS estimated at either 30 months from second‐look surgery, or 3 years from initial diagnosis, was 84% (95% CI, 68%‐100%).CONCLUSIONS.Consolidation i.p. topotecan is a feasible option for women withadvanced ovarian and primary peritoneal cancers. Further investigation of i.p. topotecan is warranted in this patient population. Cancer 2008. © 2008 American Cancer Society.

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Phase III Randomized Trial of 12 Versus 3 Months of Maintenance Paclitaxel in Patients With Advanced Ovarian Cancer After Complete Response to Platinum and Paclitaxel-Based Chemotherapy: A Southwest Oncology Group and Gynecologic Oncology Group Trial

Abstract: Twelve cycles of single-agent paclitaxel administered to women with advanced ovarian cancer who attain a clinically defined complete response to initial platinum/paclitaxel-based chemotherapy significantly prolongs the duration of PFS.

Cited by 423 publications

References 17 publications

Osteopontin as an Adjunct to CA125 in Detecting Recurrent Ovarian Cancer

Osteopontin as an Adjunct to CA125 in Detecting Recurrent Ovarian Cancer

BRCA1 and BRCA2 mutations correlate with TP53 abnormalities and presence of immune cell infiltrates in ovarian high-grade serous carcinoma

Phase 2 study of intraperitoneal topotecan as consolidation chemotherapy in ovarian and primary peritoneal carcinoma

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