Louise Catherine Connell

Are Dose-Dense and Triplet Chemotherapy Regimens Optimal Adjuvant Therapy in the Majority of Women With Node-Positive Early Breast Cancer?

ful. The US Food and Drug Administration has similarly proposed expansion of access to data submitted in regulatory applications. Mello et al recently proposed a framework for broad sharing of participant-level data from clinical trials and related documents. Four possible data-sharing models are proposed, varying in who the decision maker would be for releasing these data. As of October 25, 2013, over 154,000 studies have been listed on clinicaltrials.gov. This represents millions of clinical trial participants whose impact on health care is only magnified by the opportunity for additional gains from their efforts. We wholeheartedly agree with the sentiments of Read, although, as the US Food and Drug Administration and EMA outline, these databases will undoubtedly include privately and publicly funded clinical trial data. The devil is in the details.

Cost Effectiveness and Cancer Drugs

patient populations may place greater relevance on different aspects with younger, fitter patients placing more importance on extending OS and older, frailer patients placing more importance on QOL. Composite end points may better reflect what matters to the elderly patients such as QOL-adjusted survival, which is used by payers to assess the benefit of a treatment for society. We disagree that composite end points predispose to type II error if competing risks were appropriately incorporated in the trial design and power determination. We agree with Mell et al, that coprimary end points are good alternatives to composite end points and believe they will be useful for elderly trials as they reflect the multidimensionality of treatment outcome.

Combined intrahepatic cholangiocarcinoma and hepatocellular carcinoma

Hepatocellular carcinoma (HCC), the fifth most common cancer globally and third leading cause of cancer-related mortality is a heterogeneous disease with a highly variable clinical course. The inherent biological diversity of hepatic carcinomas may hinder therapeutic decision making and prognostication for patients. One distinct, albeit rare, subtype of primary hepatic carcinoma is combined intrahepatic cholangiocarcinoma and hepatocellular carcinoma (cHCC-ICC), which carries an overall worse prognosis than either HCC or intrahepatic cholangiocarcinoma (ICC) alone. cHCC-ICC is a primary hepatic neoplasm containing unequivocal elements of both HCC and ICC. This review will focus on understanding further the histopathology of this unique tumor type, current treatment approaches and prognoses for this rare patient population.