Gemcitabine Plus Carboplatin Compared With Carboplatin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer: An Intergroup Trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG

Pfisterer, Jacobus; Plante, Marie; Vergote, Ignace; Bois, Andreas du; Hirte, Hal W.; Lacave, Ángel J.; Wagner, Uwe; Stähle, A.; Stuart, Gavin; Kimmig, Rainer; Olbricht, S.; Le, Tien; Emerich, Janusz; Kuhn, Walther; Bentley, J.; Jackisch, Christian; Lück, Hans-Joachim; Rochon, Justine; Zimmermann, Annamaria H.; Eisenhauer, Elizabeth

doi:10.1200/jco.2006.06.0913

Cited by 673 publications

(452 citation statements)

References 20 publications

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“…Ranges were selected from the results of 3-day cytotoxicity assays on parental cell lines (Table S3) For carboplatin and taxol a dose range of up to 20µg/ml and 120ng/ml respectively was deemed clinically relevant following pharmacokinetic studies for a dose of carboplatin at AUC 5 and taxol at 175mg/m 2 which are often administered to patients in clinical trials as single agents (du Bois et al 1997;Go et al 1999;ICON3 2002;Joerger et al 2006;Markman et al 2010;Mross et al 2000;Oguri et al 1988;Ozols et al 2003;Pfisterer et al 2006;Rowinsky 1997;Vasey et al 2004). …”

Section: Dose Optimisationmentioning

confidence: 99%

Carboplatin and taxol resistance develops more rapidly in functional BRCA1 compared to dysfunctional BRCA1 ovarian cancer cells

Busschots

O’Toole

O’Leary

et al. 2015

Experimental Cell Research

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Section: Dose Optimisationmentioning

confidence: 99%

Carboplatin and taxol resistance develops more rapidly in functional BRCA1 compared to dysfunctional BRCA1 ovarian cancer cells

Busschots

O’Toole

O’Leary

et al. 2015

Experimental Cell Research

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“…Four trials underestimated the actual outcome (A/E ratio of >1.25), Eleven trials were accurate (A/E ratio of 0.75‐1.25), and 5 trials overestimated the outcome (A/E ratio of 0.75) (Table 2). 12, 14, 17, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46 The A/E ratios ranged from 0.5 to 1.6, with a mean and median ratio of 1.0 and 1.0, respectively (Fig. 3).…”

Section: Resultsmentioning

confidence: 98%

“…It should be noted that since 1990, paclitaxel, gemcitabine, and pegylated liposomal doxorubicin have demonstrated efficacy in patients with EOC and have been approved for treatment 32, 39, 48. Most recently, antiangiogenic agents have demonstrated effectiveness in EOC clinical trials 7, 8.…”

Section: Discussionmentioning

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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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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“…When recur, the (OR) ranges from 47.2-61.7% by various combination chemotherapies: [carboplatinepidoxorubicin (Bolis et al, 2001), cyclophosphamidedoxorubicin-cisplatin (Cantu et al, 2002), carboplatinpaclitaxel (Parmar et al, 2003), and carboplatingemcitabine (Pfisterer et al, 2006)] for platinum sensitive diseases. Markedly lower OR of 6.1-25.7% was reported with single agent chemotherapies: [topotecan (ten Bokkel et al, 1997), pegylated liposomal doxorubicin (Gordon et al, 2001), weekly paclitaxel (Rosenberg et al, 2002), docetaxel (Berkenblit et al, 2004), gemcitabine (Mutch et al, 2007), and bevacizumab (Cannistra et al.…”

Section: Introductionmentioning

confidence: 99%

Personalized Cancer Treatment for Ovarian Cancer

Chumworathayi¹

2013

Asian Pacific Journal of Cancer Prevention

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Recently there have been numerous advances in understanding the genetic basis of cancer which have resulted in more appropriate treatments. In this paper we describe the experience of the Burzynski Clinic, involved in treatment of numerous patients based on personalized approach using novel combinations for difficult-to-treat malignancies, with gynecological cancers. This retrospective study was conducted by extracting data from Burzynski Clinic's medical records and comprehensive review. Among the advanced refractory ovarian cancers cases (N=33), an objective response (OR) was found in 42.4%. We anticipate that with improved technology and novel therapeutics this rate will increase and adverse events will be reduced.

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Gemcitabine Plus Carboplatin Compared With Carboplatin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer: An Intergroup Trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG

Abstract: Gemcitabine plus carboplatin significantly improves PFS and response rate without worsening quality of life for patients with platinum-sensitive recurrent ovarian cancer.

Cited by 673 publications

References 20 publications

Carboplatin and taxol resistance develops more rapidly in functional BRCA1 compared to dysfunctional BRCA1 ovarian cancer cells

Carboplatin and taxol resistance develops more rapidly in functional BRCA1 compared to dysfunctional BRCA1 ovarian cancer cells

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

Personalized Cancer Treatment for Ovarian Cancer

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