News & Views

The cancer community is deeply concerned about the unintended consequences of the current wording of the European Union (EU) draft Regulation on Data Protection, which may challenge the survival of retrospective clinical research, biobanking, and population-based cancer registries in the EU. This directive could negatively affect Europe's competitiveness in cancer research.

Hepatocellular carcinoma is a difficult-to-treat cancer and, after numerous phase III trials assessing kinase inhibitors have failed to meet their end points, sorafenib is the only accepted treatment for advanced stages of the disease. Now, the trial EVOLVE-1 has shown a lack of benefit for everolimus in the second-line treatment setting.

Cytotoxic agents are conventionally dosed on the basis of the maximum tolerated dose defined in phase I trials. A study assessing adverse events in over 2,000 patients treated with molecularly targeted agents suggests a need to redefine criteria for dosing of molecularly targeted agents, which should be based on randomized, dose-ranging phase II trials.

The PREVAIL trial compared enzalutamide and placebo in patients with metastatic castration-resistant prostate cancer who had not received prior chemotherapy, demonstrating an improvement in overall survival and other clinical, radiographic, and biochemical outcomes. Herein, the implications of these data in the rapidly changing landscape of metastatic prostate cancer therapy are discussed.

The decision of patients with breast cancer to have contralateral mastectomies is often related to their genetic risk. However, the increasing frequency of this surgical approach is also associated with social and psychological issues such as celebrity experiences and fear of contralateral breast cancer. Appropriate counselling may better inform patients' surgical choices.

Healthy individuals carrying the t(14;18) translocation might never develop follicular lymphoma (FL). However, individuals with more than 1 in 10,000 cells carrying this translocation are at high-risk of developing FL. The identification of this high-risk population will help define the pathways driving FL and designing targeted therapies to use before its development.

The recent results of the Early Breast Cancer Trialists' Cooperative Group meta-analysis have demonstrated that post-mastectomy radiotherapy reduces breast cancer recurrence and mortality in women with positive axillary lymph nodes—independently from the number of the lymph nodes involved—with no significant effect in patients with node-negative axillary status.

Over the past three decades, the interpretation of clinical trial outcomes in studies of advanced-stage non-small-cell lung cancer has changed. The robustness of findings from these trials has been called into question. We believe this change is a reflection of the improved understanding of molecular-based therapeutics and continued advances in this field.

A large definitive trial comparing the use of sentinel lymph node biopsy and elective lymph node dissection to observation in patients with intermediate thickness melanomas fails to show improved melanoma-specific survival. These results demand reconsideration of the routine use of sentinel lymph node biopsy in the treatment of primary melanoma.

The MSLT-1 study compared sentinel lymph node biopsy (SLNB) with nodal observation in patients with localized cutaneous melanoma. The final results of the trial—conducted from 1994 to 2002—strongly support using SLNB in staging patients with melanomas ≥1.0 mm in thickness, but the optimal staging approach for thinner melanomas is unanswered.

The use of antiangiogenic drugs, such as bevacizumab, represents an appealing intervention against cancer. However, not all malignancies are equally responsive to such treatment. Recent trials demonstrate the efficacy of this drug for advanced-stage cervical cancer and, despite limitations, bevacizumab provides an important clinical respite for most patients with progressive glioblastoma.

The final analysis of the MSLT-1 trial confirms that sentinel lymph node biopsy (SNLB) does not improve survival in patients with melanoma >1 mm thickness. Subgroup analyses remain inconclusive. SNLB provides prognostic information for adjuvant therapy decisions, as recent data indicate that adjuvant therapies are effective in patients with positive sentinel nodes with an ulcerated primary.

Although large, population-based studies are a powerful tool for elucidating real-world outcomes and uncommon events, confounding factors must be tightly controlled. A recent report from Nam and coauthors has neglected such a confounding factor and, therefore, stands in need of further study to clarify the findings.

A recent population-based analysis from Nam and coauthors found high complication rates occurring within 5 years of prostatectomy or radiation therapy interventions for prostate cancer. These findings emphasize that treatments should be reserved for men at significant risk of disease progression, and perhaps further concentrated into higher-volume centres of excellence.

Idelalisib, the first PI3Kδ inhibitor in clinical use, has excellent activity in patients with chronic lymphocytic leukaemia and indolent B-cell lymphomas, heralding a new era of targeted therapy for these types of cancer. Idelalisib intercepts critical communications between B cells and the microenvironment, including B-cell receptor signalling and chemokine networks.

Several clinical trials have addressed the role of adjuvant chemotherapy following neoadjuvant chemoradiation and surgery for rectal cancer. The recently published EORTC 22921 study adds further debate to the merits of adjuvant chemotherapy in this setting.

For cancer therapies to succeed, induction of an anticancer immune response is required. Immuno-oncology approaches are shaping the treatment landscape for patients with advanced-stage melanoma and other solid tumours. These new approaches may enhance immune system activity to improve outcomes, including the potential to achieve long-term survival benefits in many patients.

The recent IBIS-II clinical trial results demonstrate anastrozole reduces breast cancer incidence by 53% in postmenopausal women. While this is a major advance in prevention research, its impact on clinical practice will ultimately depend upon subject perception of risk, adverse effects and benefits of anastrozole versus other available cancer preventive therapies.

Between 2005 and 2007, mutations in JAK2 and MPL were described in most patients with myeloproliferative neoplasms (MPN). These seminal discoveries have forever changed our diagnostic approach to MPN. In December 2013, mutations in CALR were reported in MPN wild-type for JAK2 and MPL. These mutations provide additional diagnostic and prognostic tools in MPN.

The recently updated HER2 testing guidelines by ASCO and the College of American Pathologists (CAP) are a significant step towards personalized medicine. It is excellent news that such great effort has been put into standardizing biomarker assessment. Undoubtedly, these recommendations will improve the analytical validity of HER2 testing, its clinical utility and the communication among health-care providers.