A equipe do MOC selecionou os abstracts de maior impacto da ASCO 2014. Veja abaixo os destaques em Melanoma:

Melanoma

• BRIM8: A phase III, randomized, double-blind, placebo-controlled study of vemurafenib adjuvant therapy in patients with surgically resected, cutaneous BRAF-mutant melanoma at high risk for recurrence (NCT01667419)
• Improved median overall survival (OS) in patients with metastatic melanoma (mM) treated with high-dose (HD) IL-2: Analysis of the PROCLAIM 2007-2012 national registry
• Ipilimumab versus placebo after complete resection of stage III melanoma: Initial efficacy and safety results from the EORTC 18071 phase III trial
• Predictive importance of ulceration on the efficacy of adjuvant interferon-a (IFN): An individual patient data (IPD) meta-analysis of 15 randomized trials in more than 7,500 melanoma patients (pts)

Melanoma

BRIM8: A phase III, randomized, double-blind, placebo-controlled study of vemurafenib adjuvant therapy in patients with surgically resected, cutaneous BRAF-mutant melanoma at high risk for recurrence (NCT01667419)

Abstract No: TPS9118^
Author(s): Karl D. Lewis, Michele Maio, Mario Mandalà, et al.
Pts aged ≥18 yrs with histologically confirmed stage IIC or III BRAFV600mutation-positive (by cobas testing) melanoma of cutaneous origin that has been completely resected are eligible. Pts without clinical or radiologic evidence of regional lymph node involvement must undergo sentinel lymph node biopsy, and those with evidence of regional or sentinel lymph node involvement must undergo complete regional lymphadenectomy. Pts with a history of systemic therapy for treatment or prevention of melanoma (including interferon alfa-2b) are ineligible. Two cohorts (C) will enroll ~ 725 pts: C1—500 pts with completely resected stage IIC, IIIA (one or more nodal metastasis >1 mm in diameter, per Rotterdam classification), or IIIB cutaneous melanoma; C2—225 pts with stage IIIC cutaneous melanoma. Pts will be randomized 1:1 to receive VEM (960 mg bid) or placebo for 52 weeks with randomization stratified by pathologic stage and region (C1) and by region (C2). Primary efficacy outcome measure is investigator-assessed disease-free survival. Secondary efficacy outcome measures include overall and distant metastasis-free survival. Safety, pharmacokinetic, and pt-reported outcomes will also be assessed. As of 13 Jan 2014, 179/196 sites are active and 154 pts have been randomized (C1: 89; C2: 65).

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Improved median overall survival (OS) in patients with metastatic melanoma (mM) treated with high-dose (HD) IL-2: Analysis of the PROCLAIM 2007-2012 national registry

Abstract No: 9054
Type: General Poster Session
Time: Saturday May 31, 8:00 AM to 11:45 AM
Location: S Hall A2
Author(s): Gregory A. Daniels, Michael Morse, Michael K.K. Wong, et al.
The PROCLAIM registry (www.proclaimregistry.com), a HD IL-2 observational database currently with over 30 participating sites, consists of a retrospective cohort (treated 2007-2012) informing an ongoing prospective cohort (~600 patients). We report on the retrospective mM subjects (n=170, 11 sites) with survival status determined as of 11/2013 and a median follow-up of 30.5 months. Sites were encouraged to enroll patients sequentially. Inclusion criteria required that patients have received at least one dose of HD IL-2. Median OS has not been The PROCLAIM registry documents an improvement in OS for patients treated with HD IL-2 as compared to the historical reference standards. Response to HD IL-2 traditionally defined as CR or PR and, according to this data, should also include SD, which can be very durable. The observation that 1st and 2nd line HD IL-2 possessed similar OS raises intriguing hypotheses about the sequencing of immunotherapy and targeted therapy in mM, and the utility of IL-2 as a salvage option – all of which are currently under examination in the prospective database.

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Ipilimumab versus placebo after complete resection of stage III melanoma: Initial efficacy and safety results from the EORTC 18071 phase III trial

Abstract No: LBA9008
Type: Oral Abstract Session
Time: Monday June 2, 3:00 PM to 6:00 PM
Location: E Arie Crown Theater
Author(s): Alexander M. Eggermont, Vanna Chiarion-Sileni, Jean Jacques Grob, et al.
The full, final text of this abstract will be posted online at 7:30 AM (EDT) on Monday, June 2.

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Predictive importance of ulceration on the efficacy of adjuvant interferon-a (IFN): An individual patient data (IPD) meta-analysis of 15 randomized trials in more than 7,500 melanoma patients (pts)

Abstract No: 9067
Type: General Poster Session
Time: Saturday May 31, 8:00 AM to 11:45 AM
Location: S Hall A2
Author(s): Stefan Suciu, Natalie Ives, Alexander M. Eggermont, et al.
Standard IPD meta-analysis methods were used to assess event-free (EFS) and overall survival (OS), with odds ratios (OR) and confidence intervals (CI) calculated. Trials were divided by dose of IFN – high (10-20MU/m2), Peg-IFN (3-6µg/Kg), intermediate (5-10MU flat), low (3MU flat) and very low (1MU). Conclusions: This meta-analysis provides evidence that adjuvant IFN significantly reduces the risk of relapse and improves overall survival. This analysis does not identify the optimal dose or duration of IFN. OS benefit was confined to pts with ulcerated tumours. The biological basis of this action is incompletely defined, and being studied in the ongoing study (EORTC 18081 and ECOG-ACRIN Intergroup Trial E1609).

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