EAL

ONC: Nutrition Status and Outcomes in Adult Oncology Patients (2013)

Citation:

Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980; 69(4): 491-497.

PubMed ID: 7424938

Study Design:

Cross-Sectional Study

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To evaluate the frequency of weight loss in a spectrum of tumor types
To evaluate the prognostic effect of weight loss on response to chemotherapy and on survival
To correlate weight loss with other prognostic factors.

Inclusion Criteria:

All patients had histologic or bone marrow (leukemia protocol) confirmation of malignancy
At the time of entry onto these protocols, the extent of disease in these patients was judged to be beyond the scope of curative surgery or radiation therapy.

Exclusion Criteria:

Patients who had previously received chemotherapy.

Description of Study Protocol:

Recruitment

The data for this study was derived from case records of patients who participated in prospective clinical trials of the Eastern Cooperative Oncology Group.

Design

Cross-sectional study.

Statistical Analysis

Statistical tests included the chi-square test for frequency distributions and the log rank test for survival distribution
Survival medians were calculated using the method of Kaplan and Meier
For most disease sites the proportion of patients still alive at the time of analysis is small
Date of death was known for 91% of the patients in protocols other than lymphoma but only 28% of the patients in the lymphoma protocols had died at the time of this analysis.

Data Collection Summary:

Timing of Measurements

Activity level (performance status) was scored using standard Eastern Cooperative Oncology Group criteria:

Zero: Fully active
One: Ambulatory, capable of light work
Two: In bed less than 50% of the time, capable of self-care but not of work activities
Three: In bed more than 50% of time, capable of only limited self-care
Four: Completely bedridden.

Dependent Variables

Incidence of weight loss: Information on weight loss during the six months prior to chemotherapy was collected by patient interview and was expressed as a percent loss compared to the patients' weight before illness and was divided into the following categories:
- None
- 0% to 5%
- 5% to 10%
- More than 10%.
Other prognostic factors such as tumor presence: Tumor involvement was coded as absent or present for three anatomic sites (liver, lung and bone). Tumor regression after chemotherapy was graded using standard criteria for all solid tumors. A complete response was defined as complete clearing of all evidence of tumor. A partial response required more than 50% decrease in the cross-sectional area of measurable tumor.

Description of Actual Data Sample:

Initial N

3,047 patients.

Attrition (final N)

3,047 patients:

290 with favorable non-Hodgkin's lymphoma
289 with breast cancer
129 with acute non-lymphocyctic leukemia
189 with sarcoma
311 with unfavorable non-Hodgkin's lymphoma
307 with colon cancer
78 with prostate cancer
436 with small cell lung cancer
590 with non-small cell lung cancer
111 with pancreas cancer
179 with non-measurable gastric cancer
138 with measurable gastric cancer.

Anthropometrics

Patients with favorable sub-types of non-Hodgkin's lymphomas, breast cancer, acute nonlymphocyctic leukemia and sarcomas had the lowest frequency of weight loss with 60% to 69% of the patients having no weight loss.

Summary of Results:

Key Findings

Within each tumor type, survival was shorter in the patients who had experienced weight loss compared with patients who had not. For nine of 12 comparisons, this difference was statistically significant.
When the data were analyzed by weight loss categories, the greatest difference was between the no weight loss and the 0% to 5% weight loss categories as shown for prostate and colorectal cancer
Representative data for cancer of the colon show that for each tumor extent category, survival was shorter in those with weight loss compared to those without.

Author Conclusion:

The authors mentioned that the analysis has relevance for the conduct of future trials of chemotherapy of cancer. In randomized trials, stratification by weight loss should be considered to assure a balance of this prognostic factor between treatment groups. Future trials should include sufficient numbers of patients in good performance and weight loss categories to provide a valid trial of the new agent.

Funding Source:

University/Hospital:	Northwestern University Medical Center, Chicago, IL
Other:	Sidney Faber Cancer Institute Boston, MA

Reviewer Comments:

The authors noted that the results from this study are noteworthy in showing that even small amounts of weight loss (less than 5 percent of body weight) may significantly worsen prognosis. Also noteworthy was the fact that weight loss was greatest in patients with a more favorable prognosis-good performance status or limited tumor extent.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	N/A
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	Yes
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	Yes
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		No
	4.1.	Were follow-up methods described and the same for all groups?	No
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	N/A
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	No
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		No
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	No
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	No
	6.6.	Were extra or unplanned treatments described?	No
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	No
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	No
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes