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American Society of Clinical Oncology 2013: summary of scientific advancements in gynecologic cancer.

ABSTRACT: The American Society of Clinical Oncology (ASCO) meeting was held in Chicago, Ill, from May 31, 2013, to June 4, 2013, and focused on "Building Bridges to Conquer Cancer." An estimated 25,500 oncology professionals, with a broad range of interests, attended the meeting. Cervical cancer, a gynecologic malignancy with a significant global burden, was prominently featured at this year's meeting. In a mark of exemplary scientific accomplishment within our specialty, 2 of the 5 general session plenaries investigated advancements in cervical cancer care, extending from improved screening to treatment of metastatic disease. This was followed by the presentation of several important phase 2 and 3 clinical trials in the Gynecologic Oncology Tract, focusing on cervical, ovarian, uterine, and breast cancer, which will be discussed in this report.

SUBMITTER: Eskander RN

PROVIDER: S-EPMC3907666 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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American Society of Clinical Oncology 2013: summary of scientific advancements in gynecologic cancer.

Eskander Ramez N RN Tewari Krishnansu S KS

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 20140101 1

The American Society of Clinical Oncology (ASCO) meeting was held in Chicago, Ill, from May 31, 2013, to June 4, 2013, and focused on "Building Bridges to Conquer Cancer." An estimated 25,500 oncology professionals, with a broad range of interests, attended the meeting. Cervical cancer, a gynecologic malignancy with a significant global burden, was prominently featured at this year's meeting. In a mark of exemplary scientific accomplishment within our specialty, 2 of the 5 general session plenar ...[more]

PMID: 24300468

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Project description:To explore the value of multiple clinical endpoints in the unique setting of ovarian cancer.A clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts.Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvantages of the numerous endpoints available are herein discussed within the unique context of ovarian cancer where both crossover and post-progression therapies potentially uncouple surrogacy between progression-free survival (PFS) and OS, the two most widely supported and utilized endpoints. The roles of patient reported outcomes (PRO) and health related quality of life (HRQoL) are discussed, but even these widely supported parameters are affected by the unique characteristics of ovarian cancer where a significant percentage of patients may be asymptomatic. Original data regarding the endpoint preferences of ovarian cancer advocates is presented.Endpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment cohort while reflecting true patient benefit. Both OS and PFS have led to regulatory approvals and are clinically important. OS remains the most objective and accepted endpoint because it is least vulnerable to bias; however, the feasibility of OS in ovarian cancer is compromised by the requirement for large trial size, prolonged time-line for final analysis, and potential for unintended loss of treatment effect from active post-progression therapies. A large magnitude of effect in PFS improvement should establish benefit, and further communication with regulatory authorities to clarify acceptable endpoints should be undertaken.

Project description:PurposeTo provide evidence-based recommendations to oncologists and others for the treatment of patients with metastatic pancreatic cancer.MethodsAmerican Society of Clinical Oncology convened an Expert Panel of medical oncology, radiation oncology, surgical oncology, gastroenterology, palliative care, and advocacy experts to conduct a systematic review of the literature from April 2004 to June 2015. Outcomes were overall survival, disease-free survival, progression-free survival, and adverse events.ResultsTwenty-four randomized controlled trials met the systematic review criteria.RecommendationsA multiphase computed tomography scan of the chest, abdomen, and pelvis should be performed. Baseline performance status and comorbidity profile should be evaluated. Goals of care, patient preferences, treatment response, psychological status, support systems, and symptom burden should guide decisions for treatments. A palliative care referral should occur at first visit. FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin; favorable comorbidity profile) or gemcitabine plus nanoparticle albumin-bound (NAB) -paclitaxel (adequate comorbidity profile) should be offered to patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 based on patient preference and support system available. Gemcitabine alone is recommended for patients with ECOG PS 2 or with a comorbidity profile that precludes other regimens; the addition of capecitabine or erlotinib may be offered. Patients with an ECOG PS ≥ 3 and poorly controlled comorbid conditions should be offered cancer-directed therapy only on a case-by-case basis; supportive care should be emphasized. For second-line therapy, gemcitabine plus NAB-paclitaxel should be offered to patients with first-line treatment with FOLFIRINOX, an ECOG PS 0 to 1, and a favorable comorbidity profile; fluorouracil plus oxaliplatin, irinotecan, or nanoliposomal irinotecan should be offered to patients with first-line treatment with gemcitabine plus NAB-paclitaxel, ECOG PS 0 to 1, and favorable comorbidity profile, and gemcitabine or fluorouracil should be offered to patients with either an ECOG PS 2 or a comorbidity profile that precludes other regimens. Additional information is available at www.asco.org/guidelines/MetPC and www.asco.org/guidelineswiki.

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American Society of Clinical Oncology 2013: summary of scientific advancements in gynecologic cancer.

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American Society of Clinical Oncology 2013: summary of scientific advancements in gynecologic cancer.

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