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. 2015 Jun;22(3):184–191. doi: 10.3747/co.22.2419

Comparing effectiveness with efficacy: outcomes of palliative chemotherapy for non-small-cell lung cancer in routine practice

LD Harrison *,†, J Zhang–Salomons *,†, M Mates ‡, CM Booth ‡,*,†, WD King *, WJ Mackillop *,†,‡,✉
PMCID: PMC4462528  PMID: 26089717

Abstract

Introduction

Randomized controlled trials (rcts) are the “gold standard” for establishing treatment efficacy; however, efficacy does not automatically translate to a comparable level of effectiveness in routine practice. Our objectives were to

  • □ describe outcomes of palliative platinum-doublet chemotherapy (ppdc) in non-small-cell lung cancer (nsclc) in routine practice, in terms of survival and well-being; and

  • □ compare the effectiveness of ppdc in routine practice with its efficacy in rcts.

Methods

Electronic treatment records were linked to the Ontario Cancer Registry to identify patients who underwent ppdc for nsclc at Ontario’s regional cancer centres between April 2008 and December 2011. At each visit to the cancer centre, a patient’s symptoms are recorded using the Edmonton Symptom Assessment System (esas). Score on the esas “well-being” item was used here as a proxy for quality of life (qol). Survival in the cohort was compared with survival in rcts, adjusting for differences in case mix. Changes in the esas score were measured 2 months after treatment start. The proportion of patients having improved or stable well-being was compared with the proportion having improved or stable qol in relevant rcts.

Results

We identified 906 patients with pre-ppdc esas records. Median survival was 31 weeks compared with 28–48 weeks in rcts. After accounting for deaths and cases lost to follow-up, we estimated that, at 2 months, 62% of the cohort had improved or stable well-being compared with 55%–63% who had improved or stable qol in rcts.

Conclusions

The effectiveness of ppdc for nsclc in routine practice in Ontario is consistent with its efficacy in rcts, both in terms of survival and improvement in well-being.

Keywords: Palliative chemotherapy, non-small-cell lung cancer, population-based studies, well-being, survival

INTRODUCTION

Randomized controlled trials (rcts) and meta-analyses have—based on improvements in survival, quality of life (qol), and symptom control—established palliative platinum-doublet chemotherapy (ppdc) as the standard of first-line care for advanced non-small-cell lung cancer (nsclc)1,2. Based on that research, multiple clinical guidelines1–3 recommend ppdc as a standard first-line treatment.

However, the efficacy demonstrated in trials does not automatically translate into a comparable level of effectiveness in the general population, and a recent Cochrane review concluded that observed differences cannot be explained by differences in study design alone (that is, rct vs. observational)4. Population-based outcome studies—which we have previously referred to as “phase iv” studies5—provide a mechanism for assessing treatment effectiveness and are therefore complementary follow-ups to practice-changing rcts6. The same approach was previously used to describe the effect of the adoption of concurrent chemoradiotherapy for cervical cancer7 and of adjuvant chemotherapy for nsclc8, and to describe survival outcomes with ppdc in advanced nsclc9.

Treatment effectiveness—in terms of qol, well-being, and symptom control—is not commonly studied at a population level because qol and symptoms are rarely captured systematically at a population level. The recent introduction of the Edmonton Symptom Assessment System (esas) for the routine assessment of symptoms in patients attending Ontario’s regional cancer centres (rccs) makes it possible to evaluate, in routine practice, the effectiveness of palliative treatment with respect to patient well-being. The esas, a 9-item clinical tool, was developed for the rapid assessment of symptoms and overall well-being10 and has been found to be valid and reliable in palliative care settings11,12.

To our knowledge, no studies have addressed the effectiveness of palliative chemotherapy for nsclc in terms of well-being or qol. The present study describes well-being and survival after first-line ppdc in nsclc patients in the general population of Ontario and compares the observed effectiveness of ppdc in routine practice with its reported efficacy in rcts.

METHODS

Study Design and Population

This retrospective cohort study of patients receiving routine care at Ontario’s rccs used the Ontario Cancer Registry (ocr)13 to identify cases of nsclc. All patients treated with standard, first-line ppdc for stage iii or iv nsclc with palliative intent at an rcc between April 2008 and December 2011 were included. First-line ppdc was defined as cisplatin or carboplatin combined with any one of gemcitabine, vinorelbine, docetaxel, or paclitaxel. Patients were excluded if they had previously received chemotherapy, curative surgery, or curative radiotherapy.

Context

Ontario is a Canadian province of approximately 13 million people with a single-payer universal health insurance program. The rccs deliver approximately 50% of all chemotherapy in the province.

Data Sources

All data used to conduct this study were provided by Cancer Care Ontario (cco). Detailed information about these data can be found on the cco Web site at https://www.cancercare.on.ca/ext/databook/db1011/whnjs.htm. The ocr provided information about patient age, sex, vital status, and date of death. Information about TNM stage was linked to the ocr from the cco stage database, in which stage capture for lung cancer is 86% for cases diagnosed in 200814 and more than 90% for cases diagnosed from 2009 onward15. The Canadian Institute for Health Information’s Discharge Abstract Database (details available at http://www.cihi.ca/cihi-ext-portal/internet/en/document/types+of+care/hospital+care/acute+care/dad_metadata) was linked to the ocr to provide information about surgery. Records of radiotherapy were linked to the ocr from cco’s Radiation Planning/Treatment Activity database. Records of chemotherapy were linked to the ocr from the cco Systemic Drug Delivery Event database to provide detailed information about all chemotherapy administered at Ontario’s rccs, including treatment intent, type of drug, and date of drug administration. The database is populated by cco’s automated drug prescribing system, which is used exclusively at the rccs and is therefore of high quality. Scores from the esas were linked to the ocr from cco’s Symptom Management Reporting Database.

Survival

Survival was calculated from the date of first ppdc. Dates of death were complete to November 2011. Patients alive at that time were censored. Factors associated with survival were evaluated using Cox regression. Median survival in the routine-care cohort was compared with that reported in relevant phase iii rcts. Five rcts were selected for survival comparisons16–20 based on their exclusive use of ppdc regimens (including platinum plus a new agent) and their inclusion in a 2010 systematic review of first-line systemic chemotherapy for advanced nsclc21 or one of two meta-analyses cited within that review22,23 that focused only on ppdc regimens consisting of platinum plus a new agent. Two additional rcts were selected based on their reporting of detailed qol results24,25. To account for differences in case mix (age, sex, stage, and histology), the mean of covariates method was used to standardize median survival in the cohort with that in the comparator rcts26.

Well-Being and Symptomatic Status

Scores on the esas measure well-being and 8 common cancer symptoms. Patients rate their well-being and symptoms on an 11-point scale from 0 (best) to 10 (worst). The esas data can be entered electronically by the patient or completed on paper and then uploaded by clinic staff12. Since 2008, cco has used the esas in an attempt to assess all patients at every rcc visit. Collection of esas data is still incomplete, but by 2010, 59% of lung cancer patients seen at rccs were being assessed by esas at least once each month27.

Baseline esas scores were defined as those measured within the 30 days before (including the date of) the first chemotherapy treatment. Baseline scores were categorized as mild or absent (0–3), moderate (4–6), or severe (7–10) based on cut-offs previously suggested28. The single esas well-being item was selected as a proxy for general qol in our study.

The definition of 2-month esas scores was those measured at 2 months (8 weeks ± 2 weeks after the first chemotherapy treatment and before the 3rd cycle) to coincide with the end of the 2nd cycle of treatment. Patient well-being at 2 months was classified as improved, stable, or deteriorated based on change in the esas score from baseline to 2 months (Figure 1). An increase of 2 or more points was classified as deteriorated, a change of 0 or ±1 as stable, and a decrease of 2 or more as improved. A 2-point change was selected as the cut-off point for defining a clinically meaningful difference because it was consistent with the accepted statistical method of choosing a cut-point (corresponds to 0.5 of the standard deviation of the measurement tool29, which was 1.4 points for the well-being item).

FIGURE 1.

FIGURE 1

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Frequency distribution of change in Edmonton Symptom Assessment System well-being score at 2 months (453 patients). Change in score was calculated by subtracting the 2-month score from the baseline score, such that a decline in the score represents a positive change (that is, improvement in well-being).

We identified 76 patients who were seen on 2 consecutive days with esas records for each visit. In an opportunistic test–retest comparison of the well-being scores for those patients, we found that 67% had scores within 1 point of each other. That observation suggests that a change of 2 or more points also represents a change greater than normal day-to-day variation.

The association between patient-related and disease-related characteristics and change in well-being at 2 months (dichotomized as improved or stable and deteriorated) were assessed using multivariate log binomial regression. Secondary outcomes were changes in specific symptom scores at 2 months. The change in well-being for the cohort at 2 months was also compared with the 2-month change in global qol (measured using the 30-question Quality of Life Questionnaire from the European Organisation for Research and Treatment of Cancer) reported by Gridelli et al.24 and von Plessen et al.25. Sensitivity analyses were performed to explore the nature of missing esas data at 2 months and to assess the likely impact on the analyses.

All analyses were performed using the SAS software application (version 9.3: SAS Institute, Cary, NC, U.S.A.). Our study was approved by the Health Science Research Ethics Board at Queen’s University.

RESULTS

Baseline Characteristics of the Study Population

Figure 2 describes the selection of the routine care cohort. After excluding patients who had received curative treatments, 1625 patients who had undergone ppdc were eligible for inclusion. Of those 1625 patients, 906 (56%) had a baseline esas record available for assessment. Table i describes and compares the characteristics of patients with and without a baseline esas. No statistically significant differences in age, sex, histology, or stage between the groups were observed. Moreover, the median survival in the two groups was not significantly different (32.6 weeks vs. 31.3 weeks, p = 0.51).

FIGURE 2.

FIGURE 2

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Identification of the routine care cohort. a Used in survival analysis. b Used in well-being and symptom analysis. ESAS = Edmonton Symptom Assessment System.

TABLE I.

Characteristics of the “routine care” cohort and details of the palliative platinum-doublet chemotherapy (PPDC)

Variable Patients receiving PPDC
All With baseline ESAS
No Yes
Patients (n) 1625 719 906
Age (years)
  Median 63 63 63
  Range 30–88 30–86 33–88
Sex (%)
  Men 53 53 53
  Women 47 47 47
Disease stage (%)
  III 15 15 15
  IV 85 85 85
Histology (%)
  Adenocarcinoma 53 52 53
  Squamous-cell carcinoma 15 14 16
  Other 32 34 31
Regimen (%)
  Cisplatin–gemcitabine 31 34 30
  Cisplatin–vinorelbine 11 11 11
  Carboplatin–gemcitabine 28 29 27
  Carboplatin–paclitaxel 23 20 26
  Other doubletsa 7 7 8
Cycles (%)
  1 23 24 23
  2 17 19 16
  3 17 17 17
  4 20 20 20
  5 9 8 9
  6 13 11 15
  6+ 1 1 0
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a

Cisplatin–docetaxel, carboplatin–vinorelbine, carboplatin–docetaxel. ESAS = Edmonton Symptom Assessment System.

Table ii describes the well-being and symptom status of patients before initiation of ppdc. Of baseline well-being scores, 43% were in the best or mild category, 37% in the moderate category, and 20% in the worst or severe category. Notably, 45%–56% of scores for shortness of breath, tiredness, and loss of appetite (common symptoms of advanced nsclc) fell into the moderate and severe categories; only 17% of nausea scores were moderate or severe at baseline.

TABLE II.

Baseline scores and changes at 2 months, Edmonton Symptom Assessment System

Symptom Symptoms at baseline [% (n=906)] Change at 2 monthsa [% (n=453)]
Best or mild Moderate Worst or severe Improved Stable Deteriorated
Well-being 43 37 20 51 20 29
Pain 61 23 16 45 30 25
Shortness of breath 54 24 22 42 25 33
Tiredness (fatigue) 44 31 25 41 22 37
Loss of appetite 51 30 19 41 26 34
Nausea 84 12 5 21 49 30
Drowsiness 66 21 14 33 30 37
Anxiety 59 25 16 45 31 24
Depression 72 18 10 34 40 27
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a

Responses at 2 months were categorized as improved/stable/deteriorated as shown in Figure 1.

Treatment

Table i describes the platinum doublets and numbers of cycles of chemotherapy that patients received. Cisplatin-based doublets were given to 43%, and carboplatin-based doublets, to 57%. Fewer than half the patients (42%) completed 4–6 cycles; 23% completed only 1 cycle. The specific platinum doublets used and the number of cycles completed were similar in the two groups.

Outcomes

Survival

The median overall survival in this study was 31 weeks [95% confidence interval (ci): 29 weeks to 34 weeks]. Table iii shows the results of the Cox proportional hazards regression of patient factors versus survival. Poorer baseline well-being was associated with significantly shorter survival [hazard ratio (hr) for moderate scores: 1.27; 95% ci: 1.06 to 1.51; and hr for severe scores: 1.65; 95% ci: 1.33 to 2.04]. Female sex (hr: 0.86; 95% ci: 0.73 to 1.01) and stage iii disease (hr: 0.83; 95%ci: 0.66 to 1.03) were associated with an approximate 15% reduction in the hazard, but those differences did not reach statistical significance. A slight trend toward increased risk with increasing age was observed, but was not statistically significant.

TABLE III.

Factors associated with survival in 906 patients treated with palliative platinum-doublet chemotherapy and assessable for baseline well-being

Variable Survival (weeks) Multivariate full model
Median 95% CI With well-being Without well-being
HR 95% CI HR 95% CI
Age
  30 to 49 Years 34 25 to 47 0.97 0.71 to 1.32 0.98 0.71 to 1.31
  50 to 69 Years 32 28 to 35 Reference Reference
  70 to 89 Years 31 26 to 33 1.12 0.93 to 1.35 1.12 0.93 to 1.35
Sex
  Men 29 25 to 33 Reference Reference
  Women 34 31 to 38 0.86 0.73 to 1.01 0.88 0.75 to 1.04
Stage
  III 34 29 to 40 0.83 0.66 to 1.03 0.83 0.66 to 1.03
  IV 31 28 to 34 Reference Reference
Histology
  Adenocarcinoma 34 31 to 39 Reference Reference
  Squamous cell carcinoma 30 24 to 37 1.14 0.90 to 1.44 1.14 0.96 to 1.36
  Other NSCLC 28 23 to 33 1.15 0.97 to 1.38 1.18 0.93 to 1.49
Baseline well-being
  Best 37 31 to 44 Reference
  Moderate 33 27 to 35 1.27 1.06 to 1.51
  Worst 22 18 to 27 1.65 1.33 to 2.04
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CI = confidence interval; HR = hazard ratio; NSCLC = non-small-cell lung cancer.

Comparison with RCTs:

Table iv compares the baseline characteristics of patients in the routine care cohort and in the comparison rcts. Median age in the groups was similar, but compared with the routine care cohort, the rct groups contained more men, less stage iv disease, less adenocarcinoma, and more squamous cell carcinoma.

TABLE IV.

Survival in randomized controlled trials (RCTS) compared with survival in a routine-care cohort of patients treated with palliative platinum-doublet chemotherapy

Reference Median age (years) Case mix variable (%) Survival (weeks)
Men Stage IV Adenocarcinoma Squamous cell carcinoma RCT Routine carea
Median 95% CI Median 95% CI
Scagliotti et al., 200219
  Gemcitabine–cisplatin 63 81 100 50 33 41 36 to 47 31 28 to 34
  Paclitaxel–carboplatin 62 76 100 48 32 42 37 to 48 31 28 to 34
  Vinorelbine–cisplatin 63 78 100 55 27 43 39 to 54 31 29 to 34
Schiller et al., 200220
   Paclitaxel–cisplatin 62 64 89 NR NR 34 30 to 38 33 30 to 35
  Gemcitabine–cisplatin 64 62 86 NR NR 35 31 to 40 33 30 to 35
  Docetaxel–cisplatin 63 63 86 NR NR 32 28 to 39 33 30 to 35
  Paclitaxel–carboplatin 63 62 86 NR NR 35 30 to 41 33 30 to 35
Fossella et al., 200316
  Docetaxel–cisplatin 61 72 67 44 32 48 43 to 53 33 30 to 37
  Docetaxel–carboplatin 59 72 68 42 34 40 37 to 46 33 30 to 35
  Vinorelbine–cisplatin 61 75 67 41 35 43 39 to 47 33 30 to 36
Gridelli et al., 200324,b
  Gemcitabine–cisplatin or vinorelbine–cisplatin 62 81 80 42 34 38 35 to 45 32 29 to 35
Martoni et al., 200518
  Vinorelbine–cisplatin 62 76 65 52 29 47 39 to 56 33 30 to 37
  Gemcitabine–cisplatin 63 81 56 54 28 47 39 to 56 34 31 to 38
von Plessen et al., 200625,c
  Vinorelbine–carboplatin 64 63 76 43 27 28 to 32 NR 33 30 to 36
Helbekkmo et al., 200717
  Vinorelbine–cisplatin 67 59 70 50 26 31 NR 34 31 to 37
  Gemcitabine–cisplatin 67 64 72 47 24 28 NR 33 31 to 36
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a

Adjusted for age, sex, stage, and histology to the distribution in the comparison RCT.

b

Results from the platinum-based arm only.

c

Results from the 3- and 6-cycle arms combined.

NR = not reported.

Median survival in our cohort was 31 weeks compared with 28–48 weeks in the rct groups. Given that sex, age, stage, and histology are established prognostic factors, we adjusted our survival estimates to the case mix of each comparison rct (Table iv). The adjustment resulted in the survival estimate for the routine care cohort moving closer to the survival estimates for the rct groups in three trials16,18,20, farther away in two trials17,25, and in neither direction in one trial19. The 95% cis for the adjusted survival estimates contained the rct survival estimates in three trials17,20,25.

Well-Being and Symptoms

Table ii shows the changes in esas score at 2 months. An esas record corresponding to 2 months after initiation of ppdc was available for 453 patients. Only patients who were alive and who had a completed esas at 2 months were considered in the assessment of change in esas score. Well-being had improved in 51% of patients; it was stable in 20%, and it had deteriorated in 29%. Overall, the symptom burden improved or remained stable for most patients. Some of the highest proportions of improved or stable scores were seen for the disease-related symptoms of pain (75%), shortness of breath (67%), and appetite (67%). The highest proportions of deteriorated scores were seen for treatment-related symptoms of drowsiness and tiredness (also a disease-related symptom), both at 37%.

Table v shows the results of the log binomial regression assessing the association of various patient factors with change in well-being at 2 months. In the univariate and multivariate analyses, baseline well-being was the only independent variable associated with change in well-being. Compared with patients who had at mild score at baseline, patients with moderate [relative risk (rr): 1.24; 95% ci: 1.05 to 1.47] or severe scores (rr: 1.24; 95% ci: 1.03 to 1.50) at baseline had a higher rr for improved or stable well-being at 2 months.

TABLE V.

Factors associated with changes in well-being at 2 months in 453 patients treated with palliative platinum-doublet chemotherapy and assessable after 2 months

Variable Improved or stable well-being (%) Univariate model Multivariate model
RR 95% CI RR 95% CI
Age
  30 to 49 Years 73 1.03 0.84 to 1.26 1.00 0.83 to 1.22
  50 to 69 Years 71 Reference Reference
  70 to 89 Years 72 1.02 0.89–1.17 1.01 0.89 to 1.15
Sex
  Men 71 Reference Reference
  Women 72 1.02 0.90 to 1.14 0.98 0.88 to 1.10
Stage
  III 61 0.84 0.70 to 1.01 0.91 0.79 to 1.04
  IV 73 Reference Reference
Histology
  Adenocarcinoma 73 Reference Reference
  Squamous to cell carcinoma 69 0.94 0.78 to 1.13 0.98 0.83 to 1.15
  Other NSCLC 69 0.94 0.82 to 1.07 0.98 0.86 to 1.11
Baseline well-being
  Mild 57 Reference Reference
  Moderate 77 1.34 1.16 to 1.55 1.22 1.09 to 1.36
  Severe 97 1.70 1.51 to 1.92 1.45 1.27 to 1.66
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CI = confidence interval; RR = relative risk; NSCLC = non-small-cell lung cancer.

Sensitivity Analyses:

Although the survival analyses were performed on all 906 members of the routine-care cohort, the analyses of change in well-being were restricted to patients with a completed 2-month esas (n = 453). Of the missing 453 patients, 120 had died; 333 were alive, but missing a 2-month esas. Sensitivity analyses comparing the measured 453 with the missing 333 (data not shown) found no statistically significant differences between the groups in age, sex, stage, histology, baseline well-being, number of ppdc cycles completed, or median survival. Those findings suggest that the 333 were effectively missing an esas at random rather than in any way related to patient, treatment, or outcome factors. Assuming the same distribution of improved or stable and deteriorated scores for the missing 333 patients as for the measured 453, and classifying the 120 patients who died as deteriorated, we therefore estimate that, in the full routine care cohort, 44% experienced improved well-being; 18%, stable well-being; and 38%, deteriorated well-being.

Comparison to RCTs:

The estimate of 62% of patients with improved or stable well-being from the sensitivity analyses is directly in line with estimates of improved or stable qol reported by the rcts: 63% in Gridelli et al.24 and 55% in von Plessen et al.25.

DISCUSSION AND CONCLUSIONS

Our main finding is that patients undergoing standard ppdc in routine practice achieve survival that is comparable to—and symptomatic responses that are comparable to, if not better than—those reported in rcts of ppdc.

Median survival in our cohort was consistent with the lower end of the survivals reported in rcts (range: 28–48 weeks), even after standardization to the case mix of each comparison rct. Patients in the routine care cohort were similar to those included in rcts, except for the proportions of women and of adenocarcinoma, which were both considerably higher in the current study, and of squamous cell carcinoma, which was lower. That change in case mix is consistent with recent observations30.

In the survival analysis, we found that only baseline well-being was associated with overall survival. Survival duration was significantly shorter for patients with the poorest well-being before treatment than for those with the best well-being (poorest: 22 weeks; 95% ci: 18 weeks to 27 weeks; best: 37 weeks; 95% ci: 31 weeks to 44 weeks). That observation is consistent with the results of previous studies that have shown the prognostic value of pre-treatment qol31.

At 2 months into treatment, 71% of patients reported improved or stable well-being. More than 40% of patients in the routine care cohort reported reduced scores for shortness of breath, tiredness and loss of appetite, and pain, with an additional 22%–30% of patients remaining stable.

Importantly, we observed no effect of patient age on change in well-being (those 70–89 years of age compared with those 50–69 year years: rr: 1.01; 95% ci: 0.89 to 1.15), lending further support to the growing evidence that fit elderly patients are no less likely to benefit from treatment in terms of qol8,32. The only patient factor associated with improved or stable well-being 2 months after treatment initiation was baseline well-being (moderate baseline score rr: 1.23; 95% ci: 1.09 to 1.36; severe baseline score rr: 1.45; 95% ci: 1.27 to 1.66). It is perhaps not surprising that patients whose well-being was rated worst at the outset more often felt better with treatment.

Analyses of change in well-being were restricted to those for whom a 2-month esas was available (n = 453). Of the missing 453, 120 had died, and 333 were alive but lacked a 2-month esas record. Comparisons between patients measured and unmeasured at 2 months found no statistically significantly differences in disease or treatment characteristics or in median survival, suggesting randomness of the missing esas data for the 333 patients. In sensitivity analyses, we therefore applied the improved or stable and deteriorated distributions of the measured patients to the missing patients, and classified those who had died as deteriorated. The result was an estimate that 62% of the full routine care cohort experienced improved or stable well-being, which is consistent with the 55%24 and 65%25 improved or stable qol estimates reported by the rcts.

A few methodology limitations of our study (in addition to the missing data already noted) warrant acknowledgment. The mean covariates method used for calculating adjusted survival estimates has certain limitations. This method calculates the average hazard for the average individual, which is not the same as the average survival for a group of heterogeneous individuals. The method does not perform as well as effect sizes increase and covariates become more common. A preferred alternative is the corrected group prognosis method26, but the latter method requires knowledge of the joint distribution of variables within the trial data, to which we had no access.

We used patient well-being measured by the esas as a proxy for general qol in our comparisons with the rct qol data. Although well-being and qol are certainly closely related concepts, subtle differences might make direct comparisons between the two less precise. Additionally, detailed information about performance status, treatment toxicity, and comorbidities in the present study and about baseline qol in the comparison rcts was not available and thus limited our ability to compare our results with those from the rcts. We also cannot rule out the possible influence on our results of other palliative care interventions, placebo effects, or shifts in patient response. Indeed, recent work has demonstrated that early palliative care has an independent positive effect on both qol and survival33. However, the same limitation is true of the rcts and therefore does not invalidate the efficacy–effectiveness comparison.

The chemotherapy treatment data were restricted to regimens administered to patients at Ontario’s rccs who had available baseline esas scores. Those results might therefore not be generalizable to all patients with nsclc. However, our patient group is probably more representative of the general nsclc population than are clinical trial participants. Furthermore, patient characteristics and survival in patients with and without esas scores were not substantially different, suggesting that our results might be generalizable to all patients undergoing first-line ppdc at Ontario’s rccs.

In an era of ever-increasing fiscal restraint in health care, it is imperative to ensure that treatment programs are producing their intended results. Our results suggest that the effectiveness of ppdc delivered in Ontario’s rccs is consistent with results from relevant rcts in terms of both survival and patient well-being.

ACKNOWLEDGMENTS

This work was supported by the Ontario Graduate Scholarship and R. Samuel McLaughlin Fellowship, Queen’s University, awarded to LDH.

Parts of this report are based on data and information provided by Cancer Care Ontario. However, the analysis, conclusions, opinions, and statements expressed herein are those of the authors and not necessarily those of Cancer Care Ontario.

CONFLICT OF INTEREST DISCLOSURES

We have read and understood Current Oncology’s policy on disclosing conflicts of interest, and we declare the following interests: MM has received honoraria and travel, accommodations, and expenses from Roche and has consulted for Roche and Genomic Health. The remaining authors have no disclosures to make.

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