Cisplatin, Dacarbazine With or Without Subcutaneous Interleukin-2, and Interferon Alfa-2b in Advanced Melanoma Outpatients: Results From an Italian Multicenter Phase III Randomized Clinical Trial

Ridolfi, Ruggero; Chiarion-Sileni, Vanna; Guida, Michele; Romanini, Antonella; Labianca, Roberto; Freschi, Andrea; Re, Giovanni Lo; Nortilli, Rolando; Brugnara, S.; Vitali, Patrizia; Nanni, Oriana

doi:10.1200/jco.20.6.1600

Cited by 90 publications

(42 citation statements)

References 25 publications

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“…However, until recently, all the efforts to therapeutically modulate the immune system were tempered by disappointing results from clinical trials with cancer vaccines and biochemotherapy regimens, as well as by the low response rates and high toxic effect associated with these two strategies [7][8][9][10][11][12][13][14]. A third approach known as adoptive cell therapy has shown clinical benefit for some patients although technical aspects and the complexity of the procedures have limited more widespread use [15].…”

Section: Immune Evasion As Hallmark In Cancermentioning

confidence: 99%

Targeting the PD1/PD-L1 axis in melanoma: Biological rationale, clinical challenges and opportunities

Merelli

Massi

Cattaneo

et al. 2014

Critical Reviews in Oncology/Hematology

153

108

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Section: Immune Evasion As Hallmark In Cancermentioning

confidence: 99%

Targeting the PD1/PD-L1 axis in melanoma: Biological rationale, clinical challenges and opportunities

Merelli

Massi

Cattaneo

et al. 2014

Critical Reviews in Oncology/Hematology

153

108

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“…One study 15 evaluated quality of life in the patients included in a RCT of biochemotherapy versus chemotherapy 7 . Overall quality of life significantly declined through the 5th treatment cycle with biochemotherapy (p = 0.03).…”

Section: Current Oncology-volume 15 Numbermentioning

confidence: 99%

Biochemotherapy for the Treatment of Metastatic Malignant Melanoma: A Clinical Practice Guideline

Stys-Norman¹

2008

Curr. Oncol.

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Questions• What is the role of biochemotherapy in the treatment of metastatic malignant melanoma?• What are the adverse effects and effects on quality of life of biochemotherapy as a treatment option?For the purposes of this report, "biochemotherapy" is defined as a therapeutic regimen that includes, at a minimum, chemotherapy (either single-agent or combination) and interleukin-2. PerspectivesAlthough early detection, appropriate surgery, and in some cases adjuvant therapy have improved outcomes, at least one third of patients with early-stage melanoma will develop metastases. Recently, in an effort to potentially maximize outcomes, the combination of chemotherapy and immunotherapy (biochemotherapy) was evaluated. The level of interest that this approach has generated, particularly with regard to the apparently high response rates seen in this otherwise devastating illness, was sufficient to merit closer examination by the Melanoma Disease Site Group (DSG) of Cancer Care Ontario's Program in Evidence-based Care (PEBC). OutcomesOutcomes of interest include response rate, diseasefree survival, overall survival, quality of life, and incidence of grades 3 and 4 toxicities. MethodologyEvidence was selected and reviewed by three members of the PEBC's Melanoma DSG and by two methodologists. The present practice guideline report was reviewed and approved by the Melanoma DSG, which comprises medical and radiation oncologists, surgeons, and dermatologists. External review by Ontario practitioners was obtained through a mailed survey, the results of which were incorporated into the practice guideline. Final approval of the original guideline report was obtained from the PEBC's Report Approval Panel. ResultsClinical recommendations were drafted based on the evidence identified through a systematic review. The practice guideline report with draft recommendations was mailed to Ontario practitioners for external review and to the Report Approval Panel. Feedback from both groups was incorporated into this report to create the final practice guideline. Practice GuidelineThe recommendations that follow apply to adult patients with metastatic malignant melanoma.Because of the inconsistent results of the available studies with regard to benefit (response, time to progression, and survival) and consistently high toxicity rates, biochemotherapy is not recommended for the treatment of metastatic melanoma.

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“…The primary objective of the trial was overall survival, while HRQOL evaluation was planned as a secondary objective. Further details on the clinical analysis and the HRQOL analysis are described elsewhere (Chiarion-Sileni et al, 2003;Ridolfi et al, 2002).…”

Section: The Datamentioning

confidence: 99%

Handling dropout and clustering in longitudinal multicentre clinical trials

Bianco

Borgoni

2006

Statistical Modelling

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Many clinical trials enrol patients from different medical centres. Multi-centre studies are particularly helpful in cancer research as they allow researchers to evaluate the efficacy of a therapy in a variety of patients and settings, making it possible to investigate the effect of treatments in those cases when it is difficult, or even impossible, for a single centre to recruit the required number of patients. It is often argued, however, that despite agreement among different centres to follow common standardized protocols, variation may occur in both baseline characteristics of the recruited patients and in treatment effects. This heterogeneity should be detected and, if present, accounted for in the data analysis. Furthermore, the longitudinal nature of these types of experimental studies raises the problem of attrition, that is, patients may dropout of the study for a number of reasons mainly death or disease progression. In this paper, we consider the health related quality of life of advanced melanoma patients in a longitudinal multi-centre randomized clinical trial comparing two different anti-tumoural treatments. We propose a Heckman type model to account for the possibility that patients dropout according to a non-ignorable mechanism. The model is extended to a multilevel setting to account both for the longitudinal nature and the multicentre structure of the design. We found a strong variation across centres in the quality of life evaluation. The effect of centres on the dropout was not found to be relevant in the considered data although dropout does depend on patient's characteristics.

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Cisplatin, Dacarbazine With or Without Subcutaneous Interleukin-2, and Interferon Alfa-2b in Advanced Melanoma Outpatients: Results From an Italian Multicenter Phase III Randomized Clinical Trial

Cited by 90 publications

References 25 publications

Targeting the PD1/PD-L1 axis in melanoma: Biological rationale, clinical challenges and opportunities

Targeting the PD1/PD-L1 axis in melanoma: Biological rationale, clinical challenges and opportunities

Biochemotherapy for the Treatment of Metastatic Malignant Melanoma: A Clinical Practice Guideline

Handling dropout and clustering in longitudinal multicentre clinical trials

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