Overcoming barriers to integrating patient-reported outcomes in clinical practice and electronic health records

There is burgeoning interest in integrating electronic patient-reported outcomes (PROs) into the workflow of routine cancer care. In general, this involves offering patients an interface for self-reporting their symptoms, distress, physical functioning, and other clinically oriented information through online or telephone systems, with this information conveyed to clinicians through real-time alerts and longitudinal graphic reports.

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Secondary CNS lymphoma: the poisoned needle in the haystack

The term secondary central nervous system (CNS) lymphoma (SCNSL) defines the involvement of the CNS at presentation or relapse in patients with systemic lymphoma. In the 1990s, most reported studies on SCNSL were focused on pediatric series and/or highly aggressive lymphomas. Subsequently, some retrospective studies of adult patients with 'high-grade' lymphomas aimed to identify factors predicting CNS dissemination and several series of rare extranodal lymphomas with varied risk of CNS involvement were reported. More recently, studies on the effect of rituximab on CNS recurrence rate, some proposals of risk scores and the first prospective trials focused on CNS prophylaxis or treatment of SCNSL were published. Despite all these efforts, the level of evidence remains low, and some criticisms of reported studies keep many questions open. In this issue of Annals of Oncology, Gleeson et al. [1] on behalf of the UK NCRI, add new knowledge to this challenging field. The authors analyzed CNS events in 1080 patients with diffuse large B-cell lymphomas (DLBCL) registered in the NCRI R-CHOP14vs21 trial, and, as the main findings, they report a CNS recurrence rate of 1.9% for the whole series and 2.8% for patients selected to receive CNS prophylaxis [1]. Unfortunately, the authors did not identify risk factors, probably due to the small number of events, but they documented CNS relapse sites and confirmed that prognosis of SCNSL patients is poor. The authors should be commended for the collection of a huge mass of data and for the good-sense analysis performed.

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Of mice and men: patient-derived xenografts in cancer medicine

A large proportion of oncological care is directed towards patients in whom the fraction of responders is low and the duration of response short with minimal clinical benefit. As acerbically observed by Roy Porter, 'What an ignominious destiny if the future of medicine turns into bestowing meagre increments of unenjoyed life?' [1]. Thus, it is a priority in cancer research to radically shift from therapies which are used indiscriminately across specific tumour types, to personalized therapies which can both improve efficacy and reduce unnecessary toxicities and futile treatments [2].

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ESMO-Magnitude of Clinical Benefit Scale version 1.1

Abstract

Background

The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) version 1.0 (v1.0) was published in May 2015 and was the first version of a validated and reproducible tool to assess the magnitude of clinical benefit from new cancer therapies. The ESMO-MCBS was designed to be a dynamic tool with planned revisions and updates based upon recognition of expanding needs and shortcomings identified since the last review.

Methods

The revision process for the ESMO-MCBS incorporates a nine-step process: Careful review of critiques and suggestions, and identification of problems in the application of v1.0; Identification of shortcomings for revision in the upcoming version; Proposal and evaluation of solutions to address identified shortcomings; Field testing of solutions; Preparation of a near-final revised version for peer review for reasonableness by members of the ESMO Faculty and Guidelines Committee; Amendments based on peer review for reasonableness; Near-final review by members of the ESMO-MCBS Working Group and the ESMO Executive Board; Final amendments; Final review and approval by members of the ESMO-MCBS Working Group and the ESMO Executive Board.

Results

Twelve issues for revision or amendment were proposed for consideration; proposed amendments were formulated for eight identified shortcomings. The proposed amendments are classified as either structural, technical, immunotherapy triggered or nuanced. All amendments were field tested in a wide range of studies comparing scores generated with ESMO-MCBS v1.0 and version 1.1 (v1.1).

Conclusions

ESMO-MCBS v1.1 incorporates 10 revisions and will allow for scoring of single-arm studies. Scoring remains very stable; revisions in v1.1 alter the scores of only 12 out of 118 comparative studies and facilitate scoring for single-arm studies.

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Annals of Oncology: un bon travail

It is now almost 4 years since I was appointed Editor-in-Chief of the journal Annals of Oncology by the leadership of ESMO and JSMO. I would like here to pause and reflect on what has been achieved.

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Midostaurin: a magic bullet that blocks mast cell expansion and activation

Abstract

Clinically relevant features in patients with systemic mastocytosis (SM) include the cosmetic burden of lesional skin, mediator-related symptoms, and organ damage resulting from mast cell (MC) infiltration in advanced forms of SM. Regardless of the SM variant, expansion of neoplastic MC in the skin and other organs is triggered by mutant forms of KIT, the most prevalent being D816V. Activation of MC with subsequent release of chemical mediators is often caused by IgE-dependent mechanisms in these patients. Midostaurin, also known as PKC412, blocks the kinase activity of wild-type KIT and KIT D816V, counteracts KIT-dependent growth of neoplastic MC, and inhibits IgE-dependent mediator secretion. Based on this activity-profile, the drug has been used for treatment of patients with advanced SM. Indeed, encouraging results have been obtained with the drug in a recent multi-center phase II trial in patients with advanced SM, with an overall response rate of 60% and a substantial decrease in the burden of neoplastic MC in various organs. Moreover, midostaurin improved the overall survival and relapse-free survival in patients with advanced SM compared with historical controls. In addition, midostaurin was found to improve mediator-related symptoms and quality of life, suggesting that the drug may also be useful in patients with indolent SM suffering from mediator-related symptoms resistant to conventional therapies or those with MC activation syndromes. Ongoing and future studies will determine the actual value of midostaurin-induced MC depletion and MC deactivation in these additional indications.

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Including Lynch syndrome in personalized prognostication and follow-up of stage II and III colon cancer

We read with interest the paper by Dienstmann et al. [1], in which the authors found that incorporating microsatellite instability (MSI), BRAF and KRAS mutational status to overall survival models with TNM staging increases prognostic accuracy in stage II and III colorectal cancer (CRC) patients.

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