Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200)

Alberts, David S.; Liu, P.Y.; Wilczynski, Sharon P.; Clouser, Mary C.; Lopez, Ana Maria; Michelin, David P.; Lanzotti, Victor J.; Markman, Maurie

doi:10.1016/j.ygyno.2007.08.075

Cited by 110 publications

(100 citation statements)

References 7 publications

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“…13, 15, 16, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 Twelve trials underestimated the actual OS as defined by an A/E ratio >1.25, whereas 3 trials were accurate in predicting OS as defined by an A/E ratio of 0.75 to 1.25. None of the trials overestimated the actual OS.…”

Section: Resultsmentioning

confidence: 94%

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Estimation of expectedness: Predictive accuracy of standard therapy outcomes in randomized phase 3 studies in epithelial ovarian cancer

Castonguay

Wilson

Díaz-Padilla

et al. 2014

Cancer

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BACKGROUNDThe anticipated clinical outcome of the standard/control arm is an important parameter in the design of randomized phase 3 (RP3) trials to properly calculate sample size, power, and study duration. Changing patterns of care or variation in the study population enrolled may lead to a deviation from the initially anticipated outcome. The authors hypothesized that recent changes in patterns of care in epithelial ovarian cancer (EOC) have led to challenges in correctly estimating the outcome of control groups.METHODSA systematic review of the literature was conducted for RP3 trials of EOC published between January 2000 and December 2010. The expected outcome of the control arm as well as the actual outcome achieved by this cohort was collected and a ratio (actual‐over‐expected ratio) was calculated. The estimation of outcome was deemed accurate if the outcome of the control arm was between 0.75 to 1.25 times the anticipated outcome.RESULTSA total of 35 trials were eligible for analysis. Fifteen trials had survival as the primary endpoint whereas 20 had a progression‐based primary endpoint. In total, 12 of 15 trials with a survival‐based endpoint significantly underestimated the outcome of the control arm, whereas only 4 of 20 trials with a progression‐based endpoint did. Studies with a survival endpoint underestimated outcome more frequently than those with a progression endpoint (P<.001).CONCLUSIONSSurvival of the control arm has frequently been underestimated in recent EOC RP3 trials. This underestimation means that the initial statistical assumptions of these trials may have been inaccurate. Underestimating the outcome of the control arm may result in trials being underpowered to demonstrate the absolute benefit they were designed to show. Cancer 2015;121:413–422. © 2014 American Cancer Society.

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Section: Resultsmentioning

confidence: 94%

“…A total of 3 and 7 studies were excluded from the OS15, 23, 29 and PFS17, 36, 38, 42, 43, 44, 45 analyses, respectively. This confirmed a statistically significant difference ( P = .001).…”

Section: Resultsmentioning

confidence: 99%

Estimation of expectedness: Predictive accuracy of standard therapy outcomes in randomized phase 3 studies in epithelial ovarian cancer

Castonguay

Wilson

Díaz-Padilla

et al. 2014

Cancer

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“…32 Another RCT reported the survival benefit of pegylated liposomal doxorubicin plus carboplatin compared to carboplatin alone but the results were based on accrual of only 61% of a planned 900 women. 33 The other RCT demonstrated the PFS benefit of gemcitabine plus carboplatin compared to carboplatin alone. 34 However, there have been no RCTs comparing the combination chemotherapy regimens each other.…”

Section: Best Chemotherapy Regimen For Platinum-sensitive Recurrent Omentioning

confidence: 99%

Major clinical research advances in gynecologic cancer 2009

Kim

Ryu

2009

J Gynecol Oncol

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In this review, we summarized nine major clinical advances in gynecology which occurred in 2009. For cervical cancer, the role of human papillomavirus (HPV) test as a screening test, the efficacy of HPV vaccine for middle-aged women, randomized controlled trial (RCT) regarding concurrent chemoradiation using gemcitabine plus cisplatin, and the efficacy of pazopanib for metastatic or recurrent disease were chosen. For endometrial cancer, the necessity of systematic pelvic lymphadenectomy in early endometrial cancer was reviewed. For ovarian cancer, the timing of treatment initiation for recurrent ovarian cancer, dose-dense chemotherapy as postoperative adjuvant treatment, the best chemotherapy regimen for platinum-sensitive recurrent ovarian cancer, and the efficacy of target agents were selected. In addition, the results of RCT testing the benefit of ginger in preventing post-chemotherapy nausea were examined.

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“…Two trials combined PLD with carboplatin dosed to AUC 5 and reported RRs of 52% to 62%. 80,81 The third trial dosed carboplatin at an AUC of 6 and reported slightly higher RR of 68%. [80][81][82] TTP was similar, ranging between 9 and 12 months.…”

Section: Ongoing Development Of Pldmentioning

confidence: 99%

Pegylated liposomal doxorubicin in ovarian cancer

Strother

Matei

2009

TCRM

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Abstract:The encapsulation of doxorubicin in a pegylated liposomal matrix led to a reformulated agent with a different toxicity profile and improved clinical utility. Liposomal doxorubicin is devoid of the cardiac toxicity associated with doxorubicin, but is associated with predictable muco-cutaneous toxicity. The liposomal formulation leads to improved delivery to the target tumor tissue, allowing enhanced uptake by cancer cells. These properties translate into clinical utility in recurrent ovarian cancer as demonstrated by phase II and III trials, this proven clinical efficacy leading to FDA approval in second-line therapy for ovarian cancer. New combinations with cytotoxics, in particular with carboplatin, have demonstrated an acceptable toxicity profile and clinical utility in platinum-sensitive ovarian cancer. A favorable toxicity profile renders liposomal doxorubicin an ideal partner for combination regimens with other cytotoxics, and more recently with biological agents. Such combinations are the subject of ongoing clinical trials.

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Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200)

Cited by 110 publications

References 7 publications

Estimation of expectedness: Predictive accuracy of standard therapy outcomes in randomized phase 3 studies in epithelial ovarian cancer

Estimation of expectedness: Predictive accuracy of standard therapy outcomes in randomized phase 3 studies in epithelial ovarian cancer

Major clinical research advances in gynecologic cancer 2009

Pegylated liposomal doxorubicin in ovarian cancer

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