15188 Background: In this study, we report the survival outcomes of patients with advanced pancreatic cancer who underwent intra- arterial mitomycin/cisplatin therapy at Cancer Treatment Centers of America (CTCA), a community hospital comprehensive cancer center combining conventional and integrative medical therapies. Methods: At our center, all patients undergo a comprehensive program of nutritional, spiritual, physical, naturopathic, and emotional support while receiving an aggressive conventional treatment protocol. Using data collected by the cancer registry, we identified 114 consecutively treated newly diagnosed cases of invasive pancreatic cancer who underwent definitive treatment between Jan 01 and Dec 05. Results: 26 patients were stage III and 88 were stage IV. The median age was 58 years (range 31 to 81 years). 55 patients were selected for intra-arterial therapy with mitomycin/cisplatin. These patients had a PS of 2 or better and either had no metastatic lesions or a single localized liver metastasis. 16 patients in this cohort received radiotherapy. The 59 other patients underwent a variety of therapies. Intra-arterially treated patients had a median survival of 369 days and a 2-year cumulative survival of 19%. Patients not treated with intra-arterial therapy had a median survival of 249 days and a 2-year survival of 11%. Univariate survival analysis found that patients undergoing intra-arterial therapy had significantly better survival outcomes compared to patients undergoing different therapies (Log rank test P = 0.04). The table compares the survival outcomes of recent phase III investigations on first line therapies for pancreatic cancer with those at CTCA. Conclusion: Currently, the published clinical trial data in advanced pancreatic indicates a one-year survival ranging from less than 10% to 28%. Consequently, the survival outcomes of patients undergoing therapy at our center warrant further investigation. [Table: see text] No significant financial relationships to disclose.
This phase I clinical trial evaluated the safety, tolerability, and pharmacokinetics of high-dose intravenous (i.v.) ascorbic acid as a monotherapy in patients with advanced solid tumors refractory to standard therapy.Five cohorts of three patients received i.v. ascorbic acid administered at 1 g/min for 4 consecutive days/week for 4 weeks, starting at 30 g/m² in the first cohort. For subsequent cohorts, dose was increased by 20 g/m² until a maximum tolerated dose was found.Ascorbic acid was eliminated by simple first-order kinetics. Half-life and clearance values were similar for all patients of all cohorts (2.0 ± 0.6 h, 21 ± 5 dL/h m², respectively). C(max) and AUC values increased proportionately with dose between 0 and 70 g/m², but appeared to reach maximal values at 70 g/m² (49 mM and 220 h mM, respectively). Doses of 70, 90, and 110 g/m² maintained levels at or above 10-20 mM for 5-6 h. All doses were well tolerated. No patient demonstrated an objective antitumor response.Ascorbic acid administered i.v. at 1 g/min for 4 consecutive days/week for 4 weeks produced up to 49 mM ascorbic acid in patient's blood and was well tolerated. The recommended dose for future studies is 70-80 g/m².
17541 Background: The Subjective Global Assessment (SGA) which is an easy-to-use, inexpensive, and non-invasive validated clinical instrument to assess nutritional status, combines data from subjective and objective aspects of medical history and physical examination. Since malnutrition can be a frequent manifestation in breast cancer, we investigated the prognostic role of SGA in patients with breast cancer treated in an integrative cancer treatment setting. Methods: We evaluated 305 histologically confirmed case series of breast cancer patients treated at Cancer Treatment Centers of America. Using SGA, patients were classified as well nourished (SGA A), moderately malnourished (SGA B) or severely malnourished (SGA C). Kaplan Meier method was used to calculate survival. Cox proportional hazard models were constructed to evaluate the prognostic effect of SGA independent of stage at diagnosis and prior treatment history. Results: Of 305 patients, 91 were newly diagnosed at our hospital while 214 had received prior treatment elsewhere. 69 had stage I disease at diagnosis, 131 had stage II, 51 had stage III and 41 had stage IV. The median age at diagnosis was 49 years (range 25 - 74 years). 216 patients were well-nourished (SGA A) while 89 were malnourished (SGA B or C). Well nourished patients had a median survival of 49.9 months (95% CI: 29.9 to 69.9), while malnourished patients had a median survival of 15.7 months (95% CI: 8.7 to 22.6); the difference being statistically significant (p < 0.001). Multivariate Cox modeling, after adjusting for stage at diagnosis and prior treatment history found that malnourished status was associated with a relative risk (RR) of 2.7 (95% CI: 1.8 to 4.0, p < 0.001). Stage at diagnosis was associated with a RR of 1.9 (95% CI: 1.3 to 3.0; p = 0.002) and prior treatment history was associated with a RR of 8.8 (95% CI: 4.6 to 16.9; p = 0.002). Conclusions: In this cohort, we found that low SGA scores (well-nourished status) versus high SGA scores (moderate to severe malnourished status) identified patients with better survival outcomes. At our center, we continue to investigate the role of nutritional intervention in improving prognosis in patients with breast cancer. No significant financial relationships to disclose.
20702 Background: Pain is one of the most common and disabling symptoms experienced by cancer patients. We prospectively quantified the relationship between pain and patient satisfaction with quality of life (QoL) in advanced cancer. Methods: 295 cancer patients treated at Cancer Treatment Centers of America between 10/03 and 10/05 for a minimum period of 3 months and who completed 2 QoL questionnaires at both baseline and 3 months. Pain was measured using the EORTC QLQ-C30 pain subscale. Scores ranged from 0 - 100, higher scores indicating more pain. Patient satisfaction with QoL was measured using Ferrans & Powers Quality of Life Index (QLI). Scores ranged from 0 - 30, higher scores indicating better QoL. The mean pain scores were compared using paired-samples t test across the 2 time periods at baseline and 3 months. Results: Of 295 patients, 140 were males and 155 females. 73 had breast cancer, 65 lung, 39 prostate, 33 colorectal, 12 pancreas and 73 had other cancers. 150 were newly diagnosed and 145 had received prior treatment elsewhere. The mean pain scores at baseline and 3 months were 33.9 (more pain) and 27.8 (less pain) respectively (p=0.002). Similarly, the mean QLI health scores at baseline and 3 months were 17 (low QoL) and 18.3 (better QoL) respectively (p=0.002). At baseline, after controlling for age, gender, prior treatment history, and tumor stage at diagnosis, every 10-unit increase in pain was significantly associated with 1.2 (p < 0.001), 0.26 (p = 0.001), 0.35 (p = 0.002), and 0.65 (p < 0.001) unit decrease in QLI health, social, psychological and overall QoL respectively. At 3 months, every 10-unit increase in pain was significantly associated with 1.1 (p < 0.001), 0.41 (p < 0.001), 0.42 (p = 0.004), 0.36 (p = 0.002) and 0.66 (p < 0.001) unit decrease in QLI health, social, psychological, family and overall QoL. Conclusions: We found that pain is a strong correlate of QoL independent of age, gender, prior treatment history and tumor stage at diagnosis during the first 3 months of treatment. Despite receiving aggressive cancer therapy, patients treated at our integrative cancer center reported statistically significant improvements in pain and overall QoL. No significant financial relationships to disclose.
Proc Amer Assoc Cancer Res, Volume 46, 2005
4197
Background: Substantial resources have been spent to develop validated quality of life (QoL) tools in cancer. Now QoL research is focusing on utilizing QoL measurements to improve patient outcomes. One potential clinical role for QoL information is to triage patients into good, bad, and uncertain prognosis. Consequently, we used survival analysis to determine if we could transform the continuous scales of QoL data into categorical survival outcomes. Methods: Baseline QoL data were collected from 310 patients treated at our center between 04/01 and 10/03. 2 QoL tools were used: Ferrans and Powers Quality of Life Index (QLI), which has 4 functional domains, and EORTC QLQ-C30, which has 5 functional domains and 9 symptom items. Using the Wilcoxon test, differences in survival were measured in serial increments of 10 points for EORTC and 3 points for QLI (these levels are associated with significant improvement in QoL). Results from Wilcoxon test were plotted as a function of QoL cutoff points. Linear and polynomial solutions were fitted and Wald statistic identified the best fit. Results: Of 310 patients, 180 were females and 130 males, with a median age of 55 years (range 21 - 82). 64.2% had failed prior treatment. Most common cancers were breast (25%), colorectal (23.3%), and lung (17.7%). Statistical analysis indicated that Health and Function Domain (Wald Test P = 0.0194) had two cutpoints at values 10 and 20. We found a statistically significant difference in survival between patients with scores 20, the median survival being 169, 349, and 692 days respectively (p 80 were 450, 413, and 129 days respectively (p < 0.0001). Conclusions: The transformation of a QoL research tool into a clinical management tool is a challenge. As an initial step, we showed that we could convert continuous quality of life scores of the QLI Health and Functioning Domain and the rank ordered fatigue item EORTC QLQ-C30 into categorical survival outcome categories of good, bad, and uncertain. These data suggest that specific QoL domains can be powerful tools to help physicians evaluate their patients’ prognosis and subsequently, facilitate physician/patient thinking on treatment planning.
e17577 Background: Previously we reported that higher satisfaction with service quality is associated with favorable survival outcomes in a variety of cancers. However, we cautioned the readers that patients with greater satisfaction with service quality might be the ones with better self-rated health (SRH), a well-established prognosticator of cancer survival. In other words, SRH could potentially confound the patient satisfaction and survival relationship. We investigated this hypothesis in non-small cell lung cancer (NSCLC). Methods: 778 NSCLC patients (327 males and 451 females; mean age 58.8 years) treated at 4 Cancer Treatment Centers of America hospitals between July 2011 and March 2013. Patient satisfaction was measured on a 7-point scale ranging from “completely dissatisfied” to “completely satisfied”. SRH was measured on a 7-point scale ranging from “very poor” to “excellent”. Both were dichotomized into 2 categories: top box response (7) versus all others (1-6). Patient survival was the primary end point. Cox regression was used to evaluate the association between patient satisfaction and survival. Results: 74, 70, 232, and 393 patients had stage I, II, III and IV disease respectively. 631 (81%) patients were “completely satisfied”. 184 (23.7%) patients had “excellent” SRH. There was a weak but significant correlation between satisfaction and SRH (Spearman rho = 0.19; p<0.01). On univariate analysis, “completely satisfied” patients had a significantly lower risk of mortality (HR=0.75; 95% CI: 0.57-0.99; p=0.04). Similarly, patients with “excellent” SRH had a significantly lower risk of mortality (HR=0.61; 95% CI: 0.46-0.81; p=0.001). On multivariate analysis controlling for stage at diagnosis, treatment history, age, gender and hospital location, SRH was found to be a significant predictor of survival (HR=0.61; 95% CI: 0.46-0.83; p=0.001) while patient satisfaction was not (HR=0.85; 95% CI: 0.63-0.1.1; p=0.29). Conclusions: SRH appears to confound the patient satisfaction-survival relationship in NSCLC. SRH should be used as a control variable in analyses involving patient satisfaction as a predictor of clinical cancer outcomes.
19596 Background: It is uncertain whether the current Quality of Life (QL) instruments can facilitate clinical decision-making in oncology. Since the most important outcome in oncology is survival, we investigated QL domains from 2 contrasting QL instruments, EORTC QLQ-C30 and the Quality of Life Index (QLI) to determine if these instruments can partition a heterogeneous population of cancer patients into distinct prognostic groupings. Methods: 1,200 patients consented to participate in Cancer Treatment Center of America's QL program between Mar ‘01 and May ’05. We identified 494 deaths in this group. Most common tumors were breast (n=319), colon (n=159), and lung (n=209). Among 434 patients undergoing definitive treatment 159 had stage 4 and 49 had stage 3 disease, the other patients had failed definitive therapy. The median survival was 39 weeks for newly diagnosed patients and 29.9 weeks for patients with recurrent disease. We used cutpoint analysis using statistical strength of association with QL scores to determine the association between QL score and survival. This information was then used in a recursive partitioning analysis to group our cancer patient population into mutually exclusive prognostic groups. Results: We found several QL domains had a non-linear relationship with survival, which indicates that a relatively small change in QL score could result in a large change in survival. QLI Health/Functioning domain, had the strongest association with survival. Subsequent iterations of the recursive partitioning found that a combination of clinical and QL domain scores partitioned the patient population into distinct groups, whose median survival ranged from 13–100 weeks. Patients with the best prognosis had high QLI health satisfaction scores health and had hormonally dependent tumors. The patients with the poorest survival had intermediate QLI health satisfaction scores, poor appetite, and poor emotional function. Conclusion: This retrospective analysis found specific combination of QL domains and scores that partitioned patients with advanced cancer into distinct prognostic groupings. This analysis indicates that our current instruments have the potential to be developed into tools that could facilitate clinical decision-making. No significant financial relationships to disclose.
The goal of this study was to evaluate the association between patient satisfaction with quality of life (QoL) and survival in pancreatic cancer patients undergoing care in a community hospital comprehensive cancer center.A consecutive case series of 55 cases of histologically confirmed pancreatic cancer treated at Cancer Treatment Centers of America at Midwestern Regional Medical Center was studied between 04/01 and 11/04. The Quality of Life Index (QLI) was utilized to assess patient satisfaction with QoL. QLI measures global QoL as well as the QoL in four major subscales: health and physical, social and economic, psychological and spiritual, and family. All scores range from 0 to 30 with higher scores indicating a better QoL. The Kaplan-Meier method was used to calculate survival. Log-rank test was used to study the equality of survival distributions. Multivariate Cox regression analyses were then performed to evaluate the joint prognostic significance of those QoL and clinical factors that were shown to be prognostic in univariate analyses.Of the 55 patients, 28 were newly diagnosed and 27 had prior treatment history. The median age was 55 yr (range 33-74 yr). Amajority (34) had stage IV disease at diagnosis. Health and physical subscale, family subscale, and global QoL were significantly associated with survival upon univariate analysis. Health and physical subscale was marginally significant upon multivariate analysis after controlling for the effects of stage at diagnosis.We found that baseline patient satisfaction with QoL, as measured by the QLI, provides useful prognostic information in patients with pancreatic cancer. While these findings require further investigation in large patient cohorts, they may have important implications for patient stratification in clinical trials, as well as aid in clinical decision-making.
