Improving the Evidence Base for Treating Older Adults With Cancer

JCO November 10, 2015 vol. 33 no. 32 3826-3833

The American Society of Clinical Oncology (ASCO) convened a subcommittee to develop recommendations on improving the evidence base for treating older adults with cancer in response to a critical need identified by the Institute of Medicine. Older adults experience the majority of cancer diagnoses and deaths and make up the majority of cancer survivors. Older adults are also the fastest growing segment of the US population. However, the evidence base for treating this population is sparse, because older adults are underrepresented in clinical trials, and trials designed specifically for older adults are rare. The result is that clinicians have less evidence on how to treat older adults, who represent the majority of patients with cancer. Clinicians and patients are forced to extrapolate from trials conducted in younger, healthier populations when developing treatment plans. This has created a dearth of knowledge regarding the risk of toxicity in the average older patient and about key end points of importance to older adults. ASCO makes five recommendations to improve evidence generation in this population:

(1) Use clinical trials to improve the evidence base for treating older adults with cancer,

(2) leverage research designs and infrastructure for generating evidence on older adults with cancer,

(3) increase US Food and Drug Administration authority to incentivize and require research involving older adults with cancer,

(4) increase clinicians’ recruitment of older adults with cancer to clinical trials,

(5) use journal policies to improve researchers’ reporting on the age distribution and health risk profiles of research participants.

via Improving the Evidence Base for Treating Older Adults With Cancer: American Society of Clinical Oncology Statement.

Postmenopausal hormone therapy and the risk of breast cancer in Norway

International Journal of Cancer: Volume 138, Issue 3, pages 584–593, 1 February 2016


There is convincing evidence that combined estrogen–progestin therapy (EPT) increases the risk of breast cancer. However, the effect of different formulations, preparations and routes of administration is largely unknown. Estrogen only-therapy (ET) is, in general, not associated or weakly associated with breast cancer risk.

We investigated the effect of hormone therapy (HT) with ET, EPT, and tibolone on risk of invasive breast cancer. Information on HT use was obtained from the Norwegian Prescription Database, and breast cancer incidence from the Cancer Registry of Norway. Poisson regression was used to estimate the incidence rate ratios (RR). We analyzed data from 686,614 Norwegian women, aged 45–79 years in January 2004, followed until December 2008, of whom 178,383 (26%) were prescribed HT. During the average 4.8 years of follow-up, 7,910 invasive breast cancers were registered. Compared with nonusers, current users of estradiol–norethisterone acetate (NETA)(EPT) had a RR of 2.74 (95% CI: 2.55–2.95). Users of the high dose estradiol–NETA formulation Kliogest® had a RR of 3.26 (95% CI: 2.84–3.73), while users of the low dose Activelle® had a RR of 2.76 (95% CI: 2.51–3.04). Current users of tibolone had a RR of 1.91 (95% CI: 1.61–2.28). Current users of ET with oral or transdermal estradiol had a RR of 1.40 (95% CI: 1.16–1.68), and 1.40 (95% CI: 1.00–1.95), respectively. T

he increased incidence rates approximates one extra invasive breast cancer case diagnosed for every 259 women using estradiol–NETA for one year, and one extra case for every 475 women using tibolone. In conclusion, use of estradiol–NETA and tibolone preparations is associated with an increased breast cancer risk.

via Postmenopausal hormone therapy and the risk of breast cancer in Norway – Román – 2015 – International Journal of Cancer – Wiley Online Library.

Earlier cancer diagnosis in England

The proportion of cancers diagnosed as an emergency at hospital has decreased, according to Public Health England.  At the same time, the proportion of cancers diagnosed through urgent GP referral with a suspicion of cancer has increased.

PHE has published the data, which covers more than 2m patients diagnosed with cancer from 2006 to 2013. This tells us how people are diagnosed, with associated survival rates, for 56 different cancer sites and is a vital tool to help improve early diagnosis.

Impact of fertility preservation counseling and treatment on psychological outcomes among women with cancer: A systematic review

Cancer 2015;121:3938–3947

For many female cancer survivors, the preservation of reproductive potential is central to quality of life (QOL), and concerns regarding infertility may affect treatment decisions. Despite the existence of several consensus guidelines supporting routine fertility preservation consultation, to the authors’ knowledge little is known regarding psychological outcomes in female cancer patients who undergo fertility preservation counseling/consultation (FPC), with or without fertility preservation (FP).

This literature review examined the effect of FPC alone, or with FP, on psychological outcomes including satisfaction, decisional regret, and QOL. PubMed and PsychINFO were systematically searched for English-language publications from the earliest available publication date of each database through March 2015. Among 111 unique articles concerning oncofertility, 13 met inclusion criteria: peer-reviewed articles reporting primary data regarding satisfaction and psychological outcomes among women who underwent FPC alone or with FP.

A majority of women receiving FPC reported that the possibility of FP was instrumental to improved coping. Receiving FPC reduced long-term regret and dissatisfaction concerning fertility, and was associated with improved physical QOL and trends toward improved psychological QOL. Women also desired prompt, standardized, and written information addressing perceived unmet needs specific to oncofertility. Offering FPC was perceived as critical regardless of age or parity.

To the best of the authors’ knowledge, little research to date has addressed the impact of FPC alone, or with FP, on QOL in women with cancer. Clinicians should recognize the existing evidence base supporting the psychological benefit of prompt FPC. Future research must be conducted to elucidate the long-term psychosocial effects of FP.

via Impact of fertility preservation counseling and treatment on psychological outcomes among women with cancer: A systematic review – Deshpande – 2015 – Cancer – Wiley Online Library.

Five cancer drugs back on NHS list after deals with drug companies

BMJ 2015;351:h5985


Five cancer drugs have been reinstated on the list paid for by England’s Cancer Drugs Fund, after manufacturers provided discounts to make them more affordable.

The fund faces rising costs, and in September it announced the removal of 16 drugs used in 23 treatments, in an attempt to balance its books.1 Thanks to the new deal it has now been able to reinstate five, used in seven treatments, reducing the number of patients in England who would have been denied access to the drugs from 5500 to 4100.

Among the reprieved drugs is trastuzumab (Kadcyla), a Roche product capable of extending the life of patients with advanced breast cancer by six months. Its original price was £90 000 (€130 000; $140 000) a year, well above the normal threshold for drugs used at the end of life of around £50 000 per quality adjusted life year. The size of the discount offered has not been disclosed.

The other reinstated drugs are bevacizumab (Avastin), but only for cervical cancer, not for bowel or breast cancer; bosutinib (Bosulif) for chronic myeloid leukaemia; ibrutinib (Imbruvica) for chronic lymphocytic leukaemia and for mantle cell lymphoma; and brentuximab (Adcetris) for two types of lymphoma.

via Five cancer drugs back on NHS list after deals with drug companies | The BMJ.

What Do You Say When She Is No Longer Living With Cancer?

JCO November 1, 2015 vol. 33 no. 31 3668-3669

Today, I held the hand of a 37-year-old woman who I knew was dying. Yesterday, we had spoken of second-line chemotherapy, weighing the risks against the chance that it might slow the malevolent progression of her sarcoma. Today, I entered her room knowing that I had to change my story, revise the plan, darken the prognosis, look in her eyes, hold her hand, probably cry. In the past 24 hours, the urine had stopped flowing and the jaundice had arrived. Her body had made that awful transition from living with cancer to dying of it. I entered the room, heavy with the burden of knowing too much.

“How do you do what you do?” People ask me this all of the time at dinner parties or school pick-up. There is no party-ready answer. It is no different than trying to explain the pathophysiology of multisystem organ failure to a layperson; trying to explain how oncologists willingly care for people who die is just too complicated. But, sometimes, a student or a fellow is candid and courageous enough to ask me, truly seeking an answer—how do you tell a patient that she is dying?

Carry on reading via What Do You Say When She Is No Longer Living With Cancer?.

Immunotherapy response assessment in neuro-oncology: a report of the RANO working group

The Lancet Oncology: Volume 16, No. 15, e534–e542, November 2015

Immunotherapy is a promising area of therapy in patients with neuro-oncological malignancies. However, early-phase studies show unique challenges associated with the assessment of radiological changes in response to immunotherapy reflecting delayed responses or therapy-induced inflammation. Clinical benefit, including long-term survival and tumour regression, can still occur after initial disease progression or after the appearance of new lesions. Refinement of the response assessment criteria for patients with neuro-oncological malignancies undergoing immunotherapy is therefore warranted. Herein, a multinational and multidisciplinary panel of neuro-oncology immunotherapy experts describe immunotherapy Response Assessment for Neuro-Oncology (iRANO) criteria based on guidance for the determination of tumour progression outlined by the immune-related response criteria and the RANO working group. Among patients who demonstrate imaging findings meeting RANO criteria for progressive disease within 6 months of initiating immunotherapy, including the development of new lesions, confirmation of radiographic progression on follow-up imaging is recommended provided that the patient is not significantly worse clinically. The proposed criteria also include guidelines for the use of corticosteroids. We review the role of advanced imaging techniques and the role of measurement of clinical benefit endpoints including neurological and immunological functions. The iRANO guidelines put forth in this Review will evolve successively to improve their usefulness as further experience from immunotherapy trials in neuro-oncology accumulate.

Supplementary audio
Immunotherapy response assessment criteria for neuro-oncology: The Lancet Oncology. Hideho Okada discusses immunotherapy response assessment criteria in neuro-oncology.

via Immunotherapy response assessment in neuro-oncology: a report of the RANO working group – The Lancet Oncology.

Patients with relapsed/refractory chronic lymphocytic leukaemia may benefit from inclusion in clinical trials irrespective of the therapy received: a case-control retrospective analsysis

Blood Cancer Journal (2015) 5, e356

Treatment for patients with chronic lymphocytic leukaemia (CLL) keeps changing at an incredible pace, perhaps more than in any other haematological malignancy. Indeed, the outlook of patients with CLL is improving with the advent of targeted therapies, including second-generation monoclonal antibodies, immune modulators, BTK inhibitors, PI3K inhibitors and BCL2 antagonists. After decades of randomized trials showing no benefit in overall survival (OS), recent trials have changed this trend and shown a true OS benefit for patients receiving novel agents. Moreover, retrospective analyses from our and other institutions have found a significant improvement in survival over the years, suggesting that new treatments are truly changing the prognosis of the disease.

Carry on reading via Blood Cancer Journal – Patients with relapsed/refractory chronic lymphocytic leukaemia may benefit from inclusion in clinical trials irrespective of the therapy received: a case-control retrospective analsysis.