open access: Follow-up of patients who are clinically disease-free after primary treatment for fallopian tube, primary peritoneal, or epithelial ovarian cancer (Ontario/review)

open access:
Follow-up of patients who are clinically disease-free after primary treatment for fallopian tube, primary peritoneal, or epithelial ovarian cancer: a Program in Evidence-Based Care guideline adaptation 

RESULTS

Figure 1 shows a flow diagram of the search for eligible rcts or systematic reviews published after January 2010. No articles were found that met the inclusion criteria, and the Working Group members therefore agreed to endorse the recommendations from Follow Up of Women with Epithelial Ovarian Cancer with some consensus-based modifications.

 

Conclusions

The recommendations provided in this guidance document have a limited evidence base. Recommendations should be updated as further information becomes available.

 TABLE III Summary of recommendations

The cost-effectiveness of bevacizumab for the treatment of advanced ovarian cancer in Canada | Duong | Current Oncology

open access

CONCLUSIONS

The present analysis provides supportive evidence to inform the potential cost-effectiveness, in the frontline setting, of the addition of bevacizumab to standard chemotherapy in ovarian cancer patients at a high risk of progression.

(U.S./Canada/Europe) Cross-comparison of cancer drug approvals at three international regulatory agencies

open access

ABSTRACT

Background

The primary objective of the present study was to examine the drug approval process and the time to approval (tta) for cancer drugs by 3 major international regulatory bodies—Health Canada, the U.S. Food and Drug Administration (fda), and the European Medicines Agency (ema)—and to explore differences in the drug approval processes that might contribute to any disparities.....

Methods

The publicly available Health Canada Drug Product Database was surveyed for all marketed antineoplastic agents approved between 1 January 2005 and 1 June 2013. For the resulting set of cancer drugs, public records of sponsor submission and approval dates by Health Canada, the fda, and the ema were obtained.

RESULTS

To facilitate this comparative analysis of times from initial drug submission to approval by each regulatory agency, the period from the filing of a submission by a sponsor until the approval for marketing was granted was evaluated. On average, the time to approval (tta) is approximately 14.0 months for Health Canada and 14.2 months for the ema; it is 6.9 months for the fda (Tables i and ii).

Countercurrents: Do acronyms belong in the medical literature? (eg. GOG 182...)

Narod | Current Oncology

After controlling for ds, rd, an interaction term for ds/cs, performance status, age, and cell type, cs was not an independent predictor of either pfs or os.

That ungainly sentence, with its 7 acronyms (5 that are different), is taken straight from the abstract of a paper published in the Journal of Clinical Oncology in March 2015: “Does aggressive surgery improve outcomes? Interaction between preoperative disease burden and complex surgery in patients with advanced-stage ovarian cancer: an analysis of gog 182”1. The rest of the paper uses even more acronyms, which, in our opinion, make it close to unreadable—or at the very least, unpleasant to read. That feeling of unease prompted us to send a note to the editor of the journal, pleading for greater consideration of its readers with respect to the excessive use of acronyms. The literature contains many other examples, and the use of acronyms varies from journal to journal......

 We understood better what was going after we read Daniel Kahnemann’s book Thinking, Fast and Slow, wherein he discusses the internal competition in the brain4: Acronyms require an unnecessary investment of intellectual energy, which competes with the understanding of the main message. That is, either you focus on translating the acronyms or on understanding the sentence.

 REFERENCES

1. Horowitz NS, Miller A, Rungruang B, et al. Does aggressive surgery improve outcomes? Interaction between preoperative disease burden and complex surgery in patients with advanced-stage ovarian cancer: an analysis of gog 182. J Clin Oncol 2015;33:937–43.
      

2. Kressel HY. Herding bees: restricting overuse of abbreviations in biomedical literature. Radiology 2013;266:372–3.
    

3. Berlin L. tac: aoitromja? (The acronym conundrum: advancing or impeding the readability of medical journal articles?). Radiology 2013;266:383–7.
    

4. Kahnemann D. Thinking, Fast and Slow. New York, NY: Farrar, Straus, and Giroux; 2011.

5. Shiffrin RM, Nosofsky RM. Seven plus or minus two: a commentary on capacity limitations. Psychol Rev 1994;101:357–61.
    

6. Mack C. How to write a good scientific paper: acronyms [editorial]. J Micro Nanolithogr MEMS MOEMS 2012;11:040102.
  

7. Cheng TO. Acronymophilia: the exponential growth of the use of acronyms should be resisted. BMJ 1994;309:683–4.
      

8. Jacobs IJ, Menon U, Ryan A, et al. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (ukctocs): a randomised controlled trial. Lancet 2016;387:945–56.
    

9. Lee JH, Cragun D, Thompson Z, et al. Association between ihc and msi testing to identify mismatch repair–deficient patients with ovarian cancer. Genet Test Mol Biomarkers 2014;4:229–35.
  

10. McGill-Franzen A, Allington RL. Handbook of Research on Reading Disabilities. New York, NY: Routledge; 2010.

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The prioritization preferences of pan-Canadian Oncology Drug Review members and the Canadian public: a stated-preferences comparison

open access:
The prioritization preferences of pan-Canadian Oncology Drug Review members and the Canadian public: a stated-preferences comparison

 The elicitations were administered over the Internet. Respondents were asked to imagine themselves as a decision-maker responsible for allocating a fixed budget between two competing health care programs. They were told that both programs had the same cost and that the budget was not large enough to fund both of them. To provide a uniform context, respondents were told that the groups each had some form of cancer; however, specific diagnoses were not mentioned, and the alternatives were presented simply as program A and program B. Although labelled alternatives have the advantage of making hypothetical choice tasks more realistic and concrete, respondents can also use such labels to infer information that was not presented or intended as part of the task. At the extreme, respondents might ignore trade-offs between attributes and make their choices based on their perceptions of the labels alone29.....

For example, the results implied that both groups would be willing to pay more for health gains accruing to younger patients than for the same gains accruing to patients 70 years of age. The acceptability and limits of such differential valuations are not addressed in the pcodr guidelines. More explicit guidance could improve the consistency and transparency of pcodr recommendations, and in turn, public trust in the pcodr decision-making process6,37. Such transparency could also stimulate constructive debate about societal values pertaining to the allocation of public health care resources.

ABSTRACT

The pan-Canadian Oncology Drug Review (pcodr) is responsible for making coverage recommendations to provincial and territorial drug plans about cancer drugs. Within the pcodr process, small groups of experts (including public representatives) consider the characteristics of each drug and make a funding recommendation. It is important to understand how the values and preferences of those decision-makers compare with the values and preferences of the citizens on whose behalf they are acting.

In the present study, stated preference methods were used to elicit prioritization preferences from a representative sample of the Canadian public and a small convenience sample of pcodr committee members. The results suggested that neither group sought strictly to maximize quality-adjusted life year (qaly) gains and that they were willing to sacrifice some efficiency to prioritize particular patient characteristics. Both groups had a significant aversion to prioritizing older patients, patients in good pre-treatment health, and patients in poor post-treatment health. Those results are reassuring, in that they suggest that pcodr decision-maker preferences are consistent with those of the Canadian public, but they also imply that, like the larger public, decision-makers might value health gains to some patients more or less highly than the same gains to others. The implicit nature of pcodr decision criteria means that the acceptability or limits of such differential valuations are unclear. Likewise, there is no guidance as to which potential equity factors—for example, age, initial severity, and so on—are legitimate and which are not. More explicit guidance could improve the consistency and transparency of pcodr recommendations.

Viewpoint: Estimating deaths due to medical error: the ongoing controversy and why it matters

open access
 Published Online First 12 October 2016 

One important reason for the widespread attention given to the 1999 US Institute of Medicine (IOM) report To Err Is Human1 lie in its estimate that medical error was to blame for 44 000–98 000 deaths each year in the US hospitals. This striking claim established patient safety as a public concern, strengthened the case for improving the science underlying safety and motivated providers, policymakers, payers and regulators to take safety seriously. Some did express disquiet about the validity of the figures cited,2 including one of the principal investigators of the two studies that provided the data for these estimates.3

A decade and a half later, Makary and Daniel4 attribute an even higher toll to medical error: 251 454 deaths in US hospitals per year, making, they say, medical error the third-leading cause of death in the USA. Unsurprisingly, this claim generated widespread coverage in multiple media channels. It also ignited scientific controversy about the basis of the estimate and the role of mortality as a patient safety indicator (PSI). In this paper, we address this controversy and why it matters. We propose that the new estimate is very likely to be wrong. Not only is it wrong, it risks undermining rather than strengthening the cause of patient safety.

The new paper is not a study

Though the paper by Makary and Daniel was widely cited as ‘a study’, it presented no new data nor did it use formal methods to synthesise the data it used from previous studies. The authors simply took the arithmetic average of four estimates since the publication of the IOM report, including one from HealthGrades,5 a for-profit company that markets quality and safety ratings, a report from the US Office of the Inspector General (OIG)6 and two peer-reviewed articles (table 1).7 ,8 The paper did not apply any established methodology for quantitative synthesis nor did it include a discussion either of the intrinsic limitations of the studies used or of the errors associated with the extrapolation process......

NICE recommends screening for Lynch syndrome

pharma news
October 24, 2016

In new draft guidelines, the Institute says that testing all people with colorectal cancer for the condition will help identify whether the patient's family may also be at increased risk of cancer.

(media) Tennessee: Rees Skillern Cancer Institute Achieves Full Membership To The Lynch Syndrome Screening Network - Chattanoogan.com

Chattanoogan.com

(platinum resistant) Lead Researcher Discusses Promising Antibody-Drug Conjugate for Ovarian Cancer (PF-06647020)

Interview
 October 25, 2016
Results from an expansion cohort of a preliminary clinical trial have shown encouraging activity for a novel antibody-drug conjugate in patients with heavily pretreated advanced ovarian cancer.

The antibody-drug conjugate, PF-06647020, targets the protein tyrosine kinase 7 (PTK7) in these patients. PTK7 has several functions in developmental biology, including Wnt signaling and planar cell polarity. The enzyme is overexpressed in a variety of human cancers, including ovarian, breast, colon, lung, gastric, and esophageal, as well as in acute myeloid leukemia.

Six of 22 evaluable patients in the current expansion cohort responded to PF-06647020, including 1 complete response, and an additional 12 patients had stable disease. Some responses were durable, ranging from 6 to 10 months’ duration.....

OncLive: Could you provide an overview of the data you presented at ESMO?

Sachdev: This is an initial phase I exploration of an antibody-drug conjugate molecule in the clinic. It started with the traditional dose escalation design which was for patients with advanced solid tumors. And then there were preplanned expansion groups for breast cancer, non–small cell lung cancer and ovarian cancer.

The data we presented were from the expansion group for ovarian cancer, specifically, platinum-resistant ovarian cancer patients. The data from the dose escalation part were actually presented at last year’s ESMO in 2015. And once we reached our recommended phase II dose, then the planned expansions were undertaken. So today, we presented data for the 27 patients who were in the ovarian cancer expansion arm.....

AstraZeneca’s Lynparza shows significant PFS benefit in ovarian cancer patients - (Pharma)

Pharmaceutical Business Review

Ovarian cancer risks for women (media/Cleveland Clinic interview)

Ovarian cancer risks for women

Psychological Stress and Chronic Illness Among (childhood) Survivors of Cancer

medical news

The authors do not seriously discuss whether these psychological issues are related to cancer diagnosis and treatment, and may themselves be causal factors of the noted physical ailments.

References

1. Vuotto SC, Krull KR, Li C, et al. Impact of chronic disease on emotional distress in adult survivors of childhood cancer: a report from the childhood cancer survivor study. Cancer. 2016 Oct 20. doi: 10.1002/cncr.30348 [Epub ahead of print]
2. Armstrong GT, Kawashima T, Leisenring W, et al. Aging and risk of severe, disabling, life-threatening, and fatal events in the Childhood Cancer Survivor Study. J Clin Oncol. 2014;32:1218-1227.

(Italy) Is Ovarian Cancer Being Managed According to Clinical Guidelines

abstract
 

Background: In the northwestern Italian region of Piedmont, current statistics on hospitalizations show that surgical treatment for ovarian cancer (OC) is taking place in many small hospitals, as opposed to a more centralized approach. A population-based clinical audit was promoted to investigate whether OC is being managed according to clinical guidelines, identify determinants of lack of adherence to guidelines, and evaluate the association between adherence to guidelines and survival.

Patients and Methods: Residents diagnosed with OC in 2009 were identified in the regional hospital discharge records database. All hospitalizations within 2 years from diagnosis were reviewed. Patients were classified according to their initial pattern of care, defined as “with curative intent” (CIPC) if including debulking surgery aimed at maximal cytoreduction. Adherence to guidelines for surgery and chemotherapy and the effects of this adherence on OC survival were investigated with logistic regression and Cox models.

Results: The final study sample consisted of 344 patients with OC, 215 (62.5%) of whom received CIPC. Increasing age, comorbidities, and metastases were negatively associated with receiving CIPC. In the CIPC group, surgical treatment was adherent to guidelines in 35.2%, whereas chemotherapy was adherent in 87.8%. Surgical treatment that was adherent to guidelines [hazard ratio (HR), 0.72] and absence of residual tumor (HR, 0.55) were associated with better survival in the CIPC group, and chemotherapy that was adherent to guidelines was associated with a significant reduction in the risk of death (HR, 0.49).

Conclusions: Results support the need to reorganize the clinical pathway of patients with OC in the Piedmont Region and the need for better adherence to current guidelines.