OVARIAN CANCER and US: outcomes

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Showing posts with label outcomes. Show all posts
Showing posts with label outcomes. Show all posts

Saturday, April 14, 2012

abstract: Laparoscopic and laparotomic staging in stage I epithelial ovarian cancer: a comparison of feasibility and safety - oncologic safety



Laparoscopic and laparotomic staging in stage I epithelial ovarian cancer: a comparison of feasibility and safety:

Abstract

The aim of this study was to compare laparoscopic and laparotomic surgical staging in patients with stage I epithelial ovarian cancer in terms of feasibility and safety. A retrospective chart review was undertaken of all patients with apparent stage I epithelial ovarian cancer who underwent laparoscopic (laparoscopy group) or laparotomic (laparotomy group) surgical staging at the Center for Uterine Cancer, National Cancer Center, Korea, between January 2001 and August 2006. During the study period, 19 patients underwent laparotomic surgical staging and 17 patients underwent laparoscopic surgical staging. No cases were converted from laparoscopy to laparotomy. The two groups were similar in terms of age, body mass index, procedures performed, number of lymph nodes retrieved, and operating time. The laparoscopy group had less estimated blood loss (P = 0.001), faster return of bowel movement (P < 0.001), and a shorter postoperative hospital stay (P = 0.002) compared to the laparotomy group. Transfusions were required only in two laparotomy patients, and postoperative complications occurred only in four laparotomy patients. However, two patients with stage IA grade 1 and 2 disease in laparoscopy group had recurrence with one patient dying of disease. The accuracy and adequacy of laparoscopic surgical staging were comparable to laparotomic approach, and the surgical outcomes were more favorable than laparotomic approach. However, the oncologic safety of laparoscopic staging was not certain. This is the first report on the possible hazards of laparoscopic staging in early-stage ovarian cancer. In the absence of a large prospective trial, this technique should be performed cautiously.

Tuesday, March 20, 2012

REPOST: open access: Neoadjuvant Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Cancer — NEJM (multi-national study)



Neoadjuvant Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Cancer — NEJM

Original Article

Neoadjuvant Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Cancer


N Engl J Med 2010; 363:943-953September 2, 2010
Letters
In most women with ovarian carcinoma, the disease is not diagnosed until it is at an advanced stage. Primary cytoreductive surgery is considered the standard of care for advanced ovarian carcinoma.1-4 However, data from prospective, randomized, controlled trials assessing the role of primary surgery in the treatment of such cases are lacking. Interval debulking surgery has not been viewed as beneficial in women with residual tumor that exceeds 1 cm in diameter after primary debulking surgery performed with the objective of maximal surgical effort by a gynecologic oncologist.5-7 As an alternative to primary debulking surgery followed by chemotherapy, some authors have investigated the use of neoadjuvant chemotherapy before cytoreductive surgery. However, results of a meta-analysis involving 835 patients suggested that neoadjuvant chemotherapy, as compared with primary debulking surgery, was associated with a worse outcome.8
We report on a randomized trial in which we compared primary debulking surgery followed by platinum-based chemotherapy and platinum-based neoadjuvant chemotherapy followed by interval debulking surgery and additional platinum-based chemotherapy in women with advanced ovarian carcinoma.............


Tuesday, March 13, 2012

Editorial: The Relationship Between Cost and Quality, No Free Lunch - March 14, 2012 — JAMA + link to original article



The Relationship Between Cost and Quality, March 14, 2012, Joynt and Jha 307 (10): 1082 — JAMA
 Editorial: The Relationship Between Cost and Quality 
No Free Lunch

Since this article does not have an abstract, we have provided the first 150 words of the full text. (Blogger's Note: subscription required to view $$$)
"For the past 30 years, research from investigators at Dartmouth has demonstrated large and persistent variations in costs and quality across the US health care system. Beyond simply showing that cost and quality vary by geography, the Dartmouth Atlas has demonstrated that in many communities, care is so fragmented and ineffective that greater spending on Medicare beneficiaries often leads to worse outcomes1,2 because some patients receive services that are redundant and low value and that may even have substantial risks. 

However, some US policy makers have misinterpreted the Dartmouth research and in the troves of data have found what they believe to be a free lunch: given the inverse relationship between costs and quality, it follows that it should be possible to simultaneously reduce spending and improve care. Although this notion is attractive, much of the subtlety of the Dartmouth work has been lost in translation. What ....."


Related article

YouTube: Interview with Dr Stukel, Author of Hospital Spending Intensity and Patient Outcomes




Also, planning a comparison study with London School of Economics and Havard

open access: Association of Hospital Spending Intensity With Mortality and Readmission Rates in Ontario (Canada) Hospitals, March 14, 2012 — JAMA



 Blogger's Note: universal healthcare system, this study included colorectal cancer patients, comparisons between Canadian/U.S. systems, note authors' affiliations

Association of Hospital Spending Intensity With Mortality and Readmission Rates in Ontario Hospitals, March 14, 2012

"Our objective was to assess whether acute care patients admitted to Canadian hospitals that treat patients more intensively (and at higher cost) have lower mortality and readmissions and higher quality of care.......We studied 4 common conditions that have moderate to high incidence and mortality, that can be validly ascertained using health administrative data, and for which treatment follows relatively standard protocols. "

Design Overview

We undertook a longitudinal cohort study of patients hospitalized with selected acute clinical conditions in Ontario, Canada, and assessed the content, quality, and outcomes with respect to “exposure” to the index hospital's medical spending intensity. Medical intensity is defined as the quantity of medical care provided overall to similarly ill patients and is a marker of a hospital's propensity to treat similarly ill patients more (or less) intensively. It reflects the component of spending variation attributable to practice style rather than to differences in illness or price.
Because sicker patients use more services, higher-spending hospitals may appear to have worse outcomes, in part because patients are more severely ill. We used several techniques to remove this potential “reverse causality,” as in previous work.1,2​,3,4

 COMMENT

We found that higher hospital spending intensity was associated with better survival, lower readmission rates, and better quality of care for seriously ill, hospitalized patients in Ontario in a universal health care system with more selective access to medical technology. Higher-spending hospitals were higher-volume teaching or community hospitals with high-volume or specialist attending physicians and having specialized programs, such as regional cancer centers, and specialized services, such as on-site cardiac catheterization, cardiac surgery, and diagnostic imaging facilities. The study also points to plausible mechanisms through which higher spending may be associated with better outcomes. 

Benefits appeared early, suggesting an acute-phase hospital effect. For acute conditions, timely access to preoperative and in-hospital specialist care, skilled nursing staff, rapid response teams, cardiac high-technology services, and regional cancer centers, all found in the higher-spending systems, are related to better outcomes.21​,27,34​,35,36​,37,38​,39 These systems also provided consistently, but not strikingly, higher levels of evidence-based care and collaborative ambulatory care, both shown to improve care.22​,23,40 Higher spending on evidence-based services delivered in the acute phase of care for severely ill hospitalized patients—by far the largest component of spending for our cohorts—is indeed likely to be beneficial. 

It would be facile to interpret this study as demonstrating that higher spending is causally related to better outcomes and that providing more money to lower-spending hospitals would necessarily improve their outcomes. Higher-spending hospitals differed in many ways, such as greater use of evidence-based care, skilled nursing and critical care staff, more intensive inpatient specialist services, and high technology, all of which are more expensive. 

To place the study in context, the United States has a 3- to 4-times higher per capita supply of specialized technology, such as computed tomography and magnetic resonance imaging scanners, but a similar supply of acute care beds and nurses.41 Ontario 2001 population rates of cardiac testing and revascularization lagged behind corresponding 1992 US rates and paralleled the supply of cardiologists and catheterization facilities.42​,43,44 It is therefore possible that Canadian hospitals, with fewer specialized resources, selective access to medical technology, and global budgets, are using these resources more efficiently, especially during the inpatient episode for care-sensitive conditions.45,46 Canada's health care expenditures per capita are about 57% of those in the United States.47 At this spending level, there might still be a positive association between spending and outcomes. For example, the same-day PCI rate for patients with AMI in low-intensity hospitals in 2008 was 3.5%, leaving room for improvement. This pattern is consistent with studies in the United States showing a positive association between spending and outcomes among low-intensity hospitals or regions but no association at average or higher intensity levels.5​,6

Strengths of the study include the population-based, longitudinal cohort design; the consistency of findings across cardiac, cancer, medical, and surgical patients; the examination of plausible clinical mechanisms whereby higher intensity may be associated with better outcomes; and the examination of readmissions. The “look-back” (EOL-EI) and “look-forward” (AC-EI) measures of spending intensity were highly correlated and produced similar findings, as in US studies.2
 ​
Several limitations should be considered. Because the design precludes strong inferences about causation, we cannot know which components of care may have led to better outcomes. In observational studies, comparisons of exposure groups may be biased because of unobserved selection bias.13 It is unlikely that the findings are the result of unmeasured case mix, because patients in higher-spending hospitals had similar or higher illness severity at admission, which would, if anything, bias toward finding worse outcomes. We cannot rule out the possibility that higher-intensity hospitals coded more aggressively, but there is less incentive to do so in a system with global hospital budgets. Although admission severity would be determined more accurately using clinical detail from medical charts, previous work has shown high concordance between risk-adjusted hospital outcomes using chart and administrative data.48​,49 Canadian data distinguish between comorbidities present at admission and complications, leading to improved admission severity coding. The EOL-EI has been critiqued for the purpose of estimating hospital efficiency50​,51 but is used here simply to distinguish high- and low-intensity hospitals, as in other US studies.1​,2,3​,4 The findings may not generalize to chronic conditions, for which avoiding exacerbations of disease that lead to hospitalization through coordinated ambulatory care is key. The findings also may not generalize to jurisdictions in which hospital resources are more abundant and are used in cost-effective as well as cost-ineffective ways, leading to inefficiency.45​,46

This study shows that in Ontario, a province with global hospital budgets and fewer specialized health care resources than the United States, outcomes following an acute hospitalization are positively associated with higher hospital spending intensity. Higher spending intensity, in turn, is associated with greater use of specialists, better patient care, and more use of advanced procedures. These results suggest that it is critical to understand not simply how much money is spent but whether it is spent on effective procedures and services. 

pdf file: 

http://jama.ama-assn.org/content/307/10/1037.full.pdf




Thursday, March 01, 2012

open access: Goal-Oriented Patient Care — An Alternative Health Outcomes Paradigm — NEJM



"Ultimately, good medicine is about doing right for the patient. For patients with multiple chronic diseases, severe disability, or limited life expectancy, any accounting of how well we're succeeding in providing care must above all consider patients' preferred outcomes."

Thursday, February 09, 2012

abstract: Does public disclosure of quality indicators influence hospitals' inclination to enhance results? (using Oesophageal resection as the example)




CONCLUSION:

Our results support the assumption that low-volume hospitals are inclined to adjust their numbers when, because outcomes are public, pressure to report a sufficient number is high. So, external verification of data is essential when this 'need to score' is high.

Sunday, January 29, 2012

open access: paper/Editorial - Improvements in survival of gynaecological cancer in the Anglia region of England: are these an effect of centralisation of care and use of multidisciplinary management?



Blogger's Note:  search blog for additional information on centralization of ovarian cancer surgery (eg. Norway...)

 .........................................................
Setting 
In 1999 the DH (Department of Health) in England introduced the Improving Outcomes in Gynaecological Cancer guidance, advising case management by multidisciplinary teams with surgical concentration in specialist hospitals.

In conclusion, there was a highly significant step-change increase in survival in gynaecological cancers associated with the adoption of the 1999 national policy change. ......... These changes have been most marked within endometrial and ovarian cancers.

Editorial: 

"Finally, Crawford and Greenberg on page 160 present their detailed population-based analyses of the effects of centralisation of care on survival outcomes in endometrial and ovarian cancer. Introduced in the UK in the late 1990s, the development of Cancer Networks (the ‘hub and spoke’ model) met with considerable resistance. Although it seemed intuitively right, the evidence to support such health care re-organisations was best described as weak, and they not only needed a significant investment of resources, but also required people to travel away from their immediate locality, making it difficult for friends and families to visit. Now, a number of years on, data are beginning to emerge reassuring all of the interested parties, patients in particular, that the energies and efforts required to implement the principles of centralisation of cancer services appear to have been justified."

abstract: Quality of laparoscopic radical hysterectomy in developing countries: A comparison of surgical and oncologic outcomes between a comprehensive cancer center in the United States and a cancer center in Colombia.



CONCLUSIONS:

Surgical and oncologic outcomes of laparoscopic radical hysterectomy were not worse at a cancer center in a developing country than at a large comprehensive cancer center in the United States. These results support consideration of developing countries for inclusion in collaborations for prospective surgical studies.

Friday, January 27, 2012

abstract: Long-Term Clinical Outcome of Patients With Recurrent Epithelial Ovarian Carcinoma: Is it the Same for Each Histological Type?



Abstract

Objectives: This study was conducted to estimate the long-term clinical outcome of patients with recurrent ovarian carcinoma (ROC).
Conclusions: Despite the continuous administration of treatment for ROC, survival is poor, and the extent of therapeutic progress differs according to the histological type.

Sunday, January 22, 2012

ASCO 2011 abstract: A North American population-based outcome for early-stage ovarian clear cell (stages 1-11) carcinoma (OCCC). - ASCO 2011 (including w/wo irradiation)



Abstract:
Background: OCCC is regarded as having a poor outcome and being relatively treatment resistant. Recent Japanese data instead have demonstrated high survival in early stage and radiation sensitivity. This study was carried out to reproduce/refute these findings in a North American setting.

Methods: Women with OCCC who had attended one of the four British Columbia Cancer Agency (BCCA) centers have staging, pathological, treatment, and outcome data recorded in a computerized database. Irradiation (XRT) plus platin-based chemotherapy was the standard treatment. XRT usage mandated all such women provincially attending a BCCA centre. However, individual physicians within BCCA differed in their uptake of XRT. Outcomes with or without XRT could be compared. Univariate and multivariate (decision-tree analysis) analyses for disease-free survival (DFS) were performed.

Results: 241 Stage I-II women attended between January 2000 and December 2008 (IA/IB n=64; Ic n=147; II n=30). 5 year and 10 year DFS for stage IA/B; IC and II were 85 and 70%; 64 and 58%; and 43 and 43% respectively. IC subsets faired differently: rupture alone (spontaneous and surgical were equivalent) - 5 yr DFS 80% versus 34% if cytologically positive and 43% with surface involvement. Decision-tree analysis identified cytologic positivity as the most important factor (recurrence 27% if negative, 72% if positive). Surface involvement then further subdivided the cytologically positive: surface involved 93% recurrence, if not involved 60%. XRT had no effect in stage IA (85% DFS at 5 yrs with or without it) but was superior to chemotherapy alone in IC (5 yr DFS 68% vs 58%, 10 yr DFS 63% vs 52%, HR 0.59).
Conclusions: Stage IA OCCC has an excellent long-term outcome as does IC (rupture only). IC otherwise has a poor outcome as does stage II. XRT and chemotherapy improves outcome in stage IC versus chemotherapy alone.

Saturday, January 21, 2012

abstract: Natural history and outcome of mucinous carcinoma of the ovary (women dx'd 1988 to 2007)



Blogger's Note: this conclusion therefore begs an obvious question

OBJECTIVE:

We performed a population-based analysis to compare the clinical characteristics of women with mucinous tumors with women with other epithelial tumors. (SEER stats)

 CONCLUSION:

Although survival for early-stage mucinous and serous tumors is similar, survival for advanced-stage mucinous neoplasms is inferior to that of serous carcinomas.

Saturday, January 07, 2012

open access: Letter: Survival Is Not a Good Outcome for Randomized Trials With Effective Subsequent Therapies



Link to Letter

 REFERENCES (original article)





Monday, August 15, 2011

Platinum Sensitivity–Related Germline Polymorphism Discovered via a Cell-Based Approach and Analysis of Its Association with Outcome in Ovarian Cancer Patients



Conclusion:
This study shows the potential of cell-based, genome-wide approaches to identify germline predictors of treatment outcome and highlights the need for extensive validation in patients to assess their clinical effect.

Friday, August 12, 2011

Editorial: Slow Progress in Cancer Care Disparities: HIPAA, PPACA, and CHEWBACCA… But We're Still not There! - the Oncologist



Note: full access may require registration/fee

Several factors (Table 1) appear to contribute to these differences in cancer outcomes, and these must become part of our medical consciousness as deficits that require urgent attention and/or resolution.
View this table:
Table 1.
Factors associated with disparities of cancer care
What is very clear is that this problem is not unique to the United States

Friday, July 22, 2011

Predictive Factors in Relapsed Ovarian Cancer for Complete Tumor Resection



"Results:

Overall, 177 consecutive patients (pts) were analyzed. The median age at first diagnosis was 55 years (range, 23-83 years). The complete tumor resection rate was 44.6%. Predictive factors that correlated with an adverse surgical outcome in terms of residual tumor were ascites <500 ml (Odds ratio, OR=0.3; 95% Confidence interval, CI=0.1-0.8 p<0.05), tumor involvement of the small bowel (OR=0.22; 95% CI=0.07-0.71 p<0.05), tumor spread in the upper abdomen (OR=0.33; 95% CI=0.1-0.9 p<0.05) and platinum resistance (OR=0.1, 95% CI=0.06-0.5 p<0.01).

Serous tumor histology (OR=5.8) appeared to have a protective effect. Age and initial FIGO stage were of no predictive significance.

Conclusion:

Platinum-sensitive patients without ascites, no intestinal tumor involvement, tumor restricted to middle and lower abdomen, and of serous papillary histology have significantly higher complete tumor resection rates. Prospective studies are warranted to evaluate the predictive value of these factors."

Sunday, April 24, 2011

abstract: Health Outcomes After Stopping Conjugated Equine Estrogens Among Postmenopausal Women With Prior Hysterectomy — JAMA



Health Outcomes After Stopping Conjugated Equine Estrogens Among Postmenopausal Women With Prior Hysterectomy

A Randomized Controlled Trial

Abstract

Context 

The Women's Health Initiative Estrogen-Alone Trial was stopped early after a mean of 7.1 years of follow-up because of an increased risk of stroke and little likelihood of altering the balance of risk to benefit by the planned trial termination date. Postintervention health outcomes have not been reported. 

Objective 

To examine health outcomes associated with randomization to treatment with conjugated equine estrogens (CEE) among women with prior hysterectomy after a mean of 10.7 years of follow-up through August 2009. 

Design, Setting, and Participants 

The intervention phase was a double-blind, placebo-controlled, randomized clinical trial of 0.625 mg/d of CEE compared with placebo in 10 739 US postmenopausal women aged 50 to 79 years with prior hysterectomy. Follow-up continued after the planned trial completion date among 7645 surviving participants (78%) who provided written consent. 

Main Outcome Measures 

The primary outcomes were coronary heart disease (CHD) and invasive breast cancer. A global index of risks and benefits included these primary outcomes plus stroke, pulmonary embolism, colorectal cancer, hip fracture, and death. 

Results 

The postintervention risk (annualized rate) for CHD among women assigned to CEE was 0.64% compared with 0.67% in the placebo group (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.75-1.25), 0.26% vs 0.34%, respectively, for breast cancer (HR, 0.75; 95% CI, 0.51-1.09), and 1.47% vs 1.48%, respectively, for total mortality (HR, 1.00; 95% CI, 0.84-1.18). The risk of stroke was no longer elevated during the postintervention follow-up period and was 0.36% among women receiving CEE compared with 0.41% in the placebo group (HR, 0.89; 95% CI, 0.64-1.24), the risk of deep vein thrombosis was lower at 0.17% vs 0.27%, respectively (HR, 0.63; 95% CI, 0.41-0.98), and the risk of hip fracture did not differ significantly and was 0.36% vs 0.28%, respectively (HR, 1.27; 95% CI, 0.88-1.82). Over the entire follow-up, lower breast cancer incidence in the CEE group persisted and was 0.27% compared with 0.35% in the placebo group (HR, 0.77; 95% CI, 0.62-0.95). Health outcomes were more favorable for younger compared with older women for CHD (P = .05 for interaction), total myocardial infarction (P = .007 for interaction), colorectal cancer (P = .04 for interaction), total mortality (P = .04 for interaction), and global index of chronic diseases (P = .009 for interaction). 

Conclusions 

Among postmenopausal women with prior hysterectomy followed up for 10.7 years, CEE use for a median of 5.9 years was not associated with an increased or decreased risk of CHD, deep vein thrombosis, stroke, hip fracture, colorectal cancer, or total mortality. 

A decreased risk of breast cancer persisted. 


Tuesday, February 22, 2011

Health-related quality of life and cancer clinical trials — Therapeutic Advances in Medical Oncology



"...Health-related quality of life has become a more accurate predictor of survival than some other clinical parameters, such as performance status. The overall outlook for the routine assessment of patient-reported outcomes in clinical trials is assured and, eventually, it is likely to become a standard part of clinical practice. ...."

Sunday, February 20, 2011

Platinum-based adjuvant chemotherapy on moderate - and high-risk stage I and II epithelian ovarian cancer patients. Long-term single institution exper



Background Although the optimal management of women with FIGO stages I and II epithelial ovarian cancer (EOC) is still controversial, platinum-based adjuvant chemotherapy (CT) is the mainstay of treatment. Suboptimal survival results have led to major efforts to identify prognostic factors, improve surgical staging and develop adjuvant therapies to improve patients' outcomes.

Patients and methods We evaluate in a retrospective study clinical efficacy and the toxicity profile of a platinum-based adjuvant CT in FIGO stages I and II EOC treated at our institution from March 1984 to December 2006. Grade I FIGO stages IA-IB were excluded from the analysis. In the first period (1984-1997), patients received a platinum-based regimen without taxanes. In the second period from 1997 onwards, patients were treated with carboplatin and paclitaxel. Four to six cycles of adjuvant CT were administered. Potential predictive factors of efficacy and the role of paclitaxel addition were also analysed.

Results One hundred and fifty-eight patients (60 treated with paclitaxel) met inclusion criteria and were evaluable. Median age at diagnosis was 53.7 years (range 19-81) and most patients had an Eastern Cooperative Oncology Group performance status score (ECOG) of 0-1 (91.8%); 82.9% patients had pathological stage I and 17.1% pathological stage II. With a median follow up of 8.34 years (range 4.4-11.6), 103 patients (74.1%) were free of disease and 110 of them were alive (79.1%). Median relapse-free survival (RFS) and median overall survival (OS) had not been reached at the time of the analysis. No survival difference was found between paclitaxel and carboplatin combination or non-paclitaxel-containing regimens. Statistically significant prognostic factors for better RFS in the multivariate analysis were: ECOG 0 (p=0.023; HR 0.32; 95% CI 0.17-0.57); FIGO I stage (p<0.001; HR 0.30; 95% CI 0.15-0.58); I-II histological grade (p=0.005; HR 0.38; 95% CI 0.19-0.75); mucinous histology (p=0.013; HR 0.28; 95% CI 0.13-0.53); non-surgical adherences (p<0.002, HR 0.32; 95% CI 0.15-0.54); paracolic gutters inspection (p=0.033; HR 0.50; 95% CI 0.26-0.95) and liver surface biopsies (p=0.048; HR 0.64; 95% CI 0.41-0.98).Toxicity was generally mild and non-haematologic events were the most commonly found (62.9% of the total). The most frequent haematologic toxicities were neutropenia (41.7% in all grades, 9.5% grade 3-4) and anaemia (29.1% in all grades, 3.2% grade 3-4).

Conclusions The long-term outcome of this series is comparable to the published evidence and reflects the limited activity of platinum-based CT in the adjuvant setting. The potential survival advantage of the addition of paclitaxel to carboplatin cannot be definitively answered due to the small number of patients, the limited follow-up and the retrospective nature of the study. More effective and specific treatments are clearly required, in particular for those patients with stage II and undifferentiated tumours. Quality of surgery entails prognostic value.