High-dose melphalan and autologous stem cell transplantation as consolidation treatment in patients with chemosensitive ovarian cancer: results of a single-institution randomized trial

Papadimitriou, Christos; Dafni, Urania; Anagnostopoulos, Achilles; Vlachos, Georgios; Voulgaris, Zannis; Rodolakis, Alexandros; Aravantinos, G.; Bamias, Aristotelis; Bozas, George; Kiosses, Evangelos; Gourgoulis, G.-M.; Efstathiou, Eleni; Dimopoulos, Meletios Α.

doi:10.1038/sj.bmt.1705925

Cited by 10 publications

(10 citation statements)

References 37 publications

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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%

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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: 98%

“…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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“…Courses were administered every 21 days for a maximum of 6 cycles. Four (9.8%) additional patients were treated with 6 cycles of paclitaxel and carboplatin followed by 1 cycle of high-dose melphalan (200 mg/m 2 ) with autologous peripheral blood progenitor cell (PBPC) support [16]. PBPC were mobilized with cyclophosphamide 4 g/m 2 and G-CSF.…”

Section: Resultsmentioning

confidence: 99%

“…In all cases, paclitaxel was administered at a dose of 175 mg/m 2 , over 3 h, with either carboplatin targeted at AUC 6 or cisplatin at a dose of 75 mg/m 2 . More specifically, 27 (65.9%) patients received paclitaxel and carboplatin, 4 (9.8%) the same combination followed after six courses by one cycle of melphalan 200 mg/m 2 with PBPC support [16], 9 patients (22%) were treated with paclitaxel, cisplatin and doxorubicin 50 mg/m 2 , while 1 patient (2.4%) received paclitaxel, cisplatin and ifosfamide [17]. …”

Section: Discussionmentioning

confidence: 99%

Paclitaxel- and Platinum-Based Postoperative Chemotherapy for Primary Fallopian Tube Carcinoma: A Single Institution Experience

Papadimitriou¹,

Peitsidis

Bozas³

et al. 2008

Oncology

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Background: Primary fallopian tube carcinoma (PFTC) is a rare gynecologic malignancy with very few data existing on the activity of the combination of paclitaxel with a platinum analogue as adjuvant chemotherapy. Methods: We retrospectively analyzed 41 consecutive patients with PFTC who were treated postoperatively with paclitaxel- and platinum-containing chemotherapy regimens. Results: We observed 12 (63.2%) complete and 6 (31.6%) partial responses among 19 patients with measurable disease. The median time to disease progression (TTP) for all patients was 68 months. The median overall survival (OS) for all patients has not been reached yet. The median TTP was 84 months for patients with stage I/II disease and 34 months for patients with advanced disease (p = 0.017). Median OS has not been reached yet for patients with stage I/II PFTC, while it was 63.8 months for patients with stage III/IV disease (p = 0.002). Furthermore, OS has not been reached yet for patients with optimally debulked tumors, while it was 34.1 months for patients with residual disease >2 cm (p < 0.0001). Conclusion: Adjuvant platinum- and paclitaxel-based chemotherapy should be regarded as the standard treatment in patients with PFTC. Early stage disease and optimal debulking are associated with improved TTP and OS.

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“…Results from phase III randomized high-dose chemotherapy trials with carboplatin and paclitaxel and with high-dose melphalan consolidation did not show an improvement in overall survival compared with standard-dose chemotherapy. 80,81 The panel agrees that this approach remains investigational and should not be performed outside of an approved clinical trial.…”

Section: Primary Treatmentmentioning

confidence: 99%

Epithelial Ovarian Cancer

Morgan¹,

Alvarez²,

Armstrong³

et al. 2011

J Natl Compr Canc Netw

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High-dose melphalan and autologous stem cell transplantation as consolidation treatment in patients with chemosensitive ovarian cancer: results of a single-institution randomized trial

Cited by 10 publications

References 37 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

Paclitaxel- and Platinum-Based Postoperative Chemotherapy for Primary Fallopian Tube Carcinoma: A Single Institution Experience

Epithelial Ovarian Cancer

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