<i>Objective:</i> Docetaxel and capecitabine are active agents in advanced gastric and gastroesophageal (GE) carcinomas. This multi-institutional phase II trial evaluates the combination of docetaxel and capecitabine as first- or second-line treatment in patients with advanced gastric and GE adenocarcinomas. <i>Methods:</i> Patients who had received 1 or no prior chemotherapy regimens were eligible. The chemotherapy regimen consisted of a 21-day cycle with docetaxel 30 mg/m<sup>2</sup> administered on days 1 and 8 and capecitabine 825 mg/m<sup>2</sup> administered twice daily on days 1–14. The primary end point of the study was overall survival (OS). <i>Results:</i> Forty patients were enrolled in the study; 39 received treatment and were evaluable for response and toxicity. The median patient age was 61 years (range 21–84); 8 patients had received prior chemotherapy in the advanced or metastatic setting. Grade 3/4 adverse events occurred in 15 patients (38%), including diarrhea in 5 patients (13%) and hand-foot syndrome in 5 patients (13%). The overall response rate was 32% [95% confidence interval (CI) 16.7–51.4]. The median time to progression and OS were 3.4 months (95% CI 2.7–5.8) and 10.7 months (95% CI 6.1–12.1), respectively. <i>Conclusions:</i> The regimen of docetaxel and capecitabine is a well-tolerated, easily administered and active outpatient regimen for advanced gastric and GE adenocarcinoma.
e24191 Background: The aims of this study were to screen patients for symptoms of depression, pain, and/or fatigue and test the efficacy of a stepped collaborative care (SCC) intervention compared to standard of care (SC). When compared to SC, we expected that the patients randomized to the SCC intervention would report greater improvements in patient quality of life (QoL) and lower health care utilization and costs. Family caregivers, of patients randomized to the SCC, were expected to have lower risk of cardiovascular disease when compared to family caregivers, of patients randomized to SC. Methods: Of the 459 patients and 211 caregivers enrolled in this trial, patients’ mean age was 66 years, the majority were female (56.2%) and Caucasian (92.6%). Family caregivers had a mean age of 62 years, the majority were female (69%) and Caucasian (87%). Patients were screened for clinical levels of depression, pain, and/or fatigue and then were randomized to the SCC intervention or SC arm (referral to a community provider for treatment). Family caregivers were administered questionnaires and provided blood and anthropometric data to assess risk of CVD using the ASCVD calculator. Family caregivers did not receive the intervention. Health care utilization was collected from the patients' medical record and activity-based costs were used to assess health care savings. Intent to treat analyses using general linear mixed models were employed to test the hypotheses. Results: General linear mixed models revealed an interaction of quadratic time by arm effect with patients who were randomized to the SCC intervention having greater 0-to-6-month improvement in overall QoL versus patients randomized to the SC arm [t(579) = 2.23, p = .0259]. No group difference was observed in 6-to-12 month change in QoL suggesting maintenance of gains were observed at 12 months [t(561) = -1.34, p > .10]. Multivariate analyses showed a similar pattern of more rapid gains in the subscales of QoL at 6-months in the patients randomized to the SCC intervention when compared to patients in the SC arm on the emotional well-being [t(1,856) = 2.27, p = 0.012], functional well-being [t(1, 891) = 1.73, p = 0.042]; and physical well-being subscales [t(1,777) = 1.84, p = 0.033]. Family caregivers, of patients who were randomly assigned to the SCC intervention, had lower lifetime cardiovascular risk, when compared family caregivers of patients who were randomized to the SC (uMV χ 2 =9.00, p = 0.027). Activity based costs savings of $12,546 per patient per year in activity-based costs were observed for patients randomized to the SCC intervention versus SC. The drivers of the activity-based cost savings appear to be reductions in complication and readmission rates. Conclusions: Cancer centers, and payors, interested in novel delivery and payment models may consider this integrated strategy to improve patient quality of life and save health care costs. Clinical trial information: NCT02944136 .
Background: The aim of this Phase III trial was to test the efficacy of an integrated screening and stepped collaborative care intervention (CARES) versus screening and standard of care (SC) for patients with comorbid cancer and depression, pain, and/or fatigue.Methods: The study was a parallel-group, single blind, randomized controlled trial. Outpatients with cancer and clinical levels of depression, pain, and/or fatigue were enrolled. Participants were randomly assigned in a 1:1 ratio with stratification by sex and prognostic status by cancer type. CARES is a manualized, novel stepped collaborative care intervention delivered by telemedicine. Outcomes were collected at 6- and 12-months with the primary outcome being health related quality of life (HRQoL). Secondary and tertiary outcomes included family caregiver risk of cardiovascular disease (CVD) and health care utilization and costs. Treatment allocation was masked for the biostatistician, oncologists, and outcome assessors. Findings: 459 participants and 190 family caregivers were enrolled between December 2016 to April 2021. Patients allocated to CARES had a greater 0-to-6 month improvement in HRQOL versus patients allocated to the SC arm [t(579)=2.23, p=.0259] and these gains were maintained from 6-to12-months [t(561)=-1.34, p>.10]. Patients allocated to CARES, when compared to SC, had greater 0-to-6 months improvements on the emotional [t(1,856)=2.27, p=0.012], functional [t(1, 891)=1.73, p=0.042]; and physical well-being [t(1,777)=1.84, p=0.033]. Family caregivers, of patients allocated to CARES, had lower lifetime CVD risk scores, when compared to family caregivers of patients allocated to SC [uMVχ2=9.00, p=0.027]. Cost savings of US$16,892 per patient allocated to CARES versus SC was observed. The drivers of the lower activity-based costs for CARES were shorter length of stay in the hospital, fewer emergency room visits, and trends toward fewer 90-day readmissions. Interpretation: Cancer centers may consider this integrated screening and treatment program to improve patient quality of life and save health care costs.Trial Registration: ClinicalTrials.gov NCT02939755.Funding: National Cancer Institute R01CA176809 with Administrative and Diversity Supplement; Clinical and Translation Sciences Institute UL1-TR-001857.Declaration of Interest: We declare not competing interests.Ethical Approval: Prior to the commencement of the study, the investigators received Institutional Review Board approval (PRO15030290). If the patient screened positive, they were explained the risks and benefits of the study and if provided written consent enrolled in the study.
6599 Background: Recent data reporting results of FCR therapy in previously untreated advanced CLL patients (F-25 mg/m 2 d1–3 q 4wk; C-250 mg/m 2 d 1–3 q 4wk; R-500 mg/m 2 d1 q 4wk for 6 cycles) demonstrated complete remission (CR) of 70% and overall response (OR) of 95% (J Clin Oncol 2005;23:4079). The major toxicity was grade 3/4 neutropenia during 52% of courses. One approach to decrease neutropenia without compromising efficacy could be by reducing the doses of F and C and increasing the dose of R as high-dose R has been reported to be more efficacious in CLL. Methods: We conducted a phase II study for previously untreated advanced CLL patients treated with mFCR (F-20mg/m 2 d1–3 q 4 wk; C-150 mg/m 2 d1–3 q 4 wk; R-500mg/m 2 d1 and d14 q 4wks; maintenance R-500 mg/m 2 q 3 months until progression). A Simon two-stage design was used where 15 patients were accrued in the first stage and because of acceptable toxicity and response rate in stage I an additional 35 patients will be treated. The primary endpoint was response rate. Results: Twenty patients (13 male, 7 female), age 36–85 years (median 59) were treated with a total of 105 mFCR courses. All 20 patients were evaluable for toxicity. Grade 3/4 neutropenia occurred during 11(10.5%) courses. There were no episodes of neutropenic fever. Grade 3/4 thrombocytopenia occurred during 4 (3.8%) courses. Two patients are currently on study and not evaluable for response and among the 18 evaluable patients, the CR was 68%, PR was 32% with an OR of 100%. Eleven of the 12 CR patients had no evidence of CD5 + /CD19 + coexpressing cells in their bone marrow after therapy and one had <1%; all 12 were NED by CT scan. Conclusions: Our preliminary results suggest mFCR is highly effective with considerably less grade 3/4 neutropenia than standard FCR. Complete responders had minimal residual disease in their bone marrow following mFCR. [Table: see text]
4120 Background: There is no standard-of-care second-line chemotherapy for APC. The combination of docetaxel and gefitinib, an inhibitor of epidermal growth factor receptor (EGFR) shows enhanced preclinical activity compared to docetaxel alone. Docetaxel alone has activity in APC, and this phase II trial is designed to evaluate the combination. The primary endpoint is survival with an accrual goal of 45 patients to detect an improvement to 5.25 months (mo) in median survival time by one-sided log-rank test at level α = 0.05. Methods: Patients with APC and one prior chemotherapy regimen are eligible for study; EGFR over-expression is not required. Gefitinib is administered at the dose of 250 mg/day orally without interruption. The initial dose of docetaxel was 75 mg/m 2 every three weeks (one cycle), but was reduced to 60 mg/m 2 due to a high incidence of febrile neutropenia. Results: 31 pts, all with prior gemcitabine therapy, have been enrolled on study to date, with 26 evaluable for toxicity. Patient characteristics: 62% male; 92 % with ECOG performance status 0/1, 8% ECOG of 2; median age 64 years (range 47–82 years). The best response is stable disease (5 pts), median cycles administered 2 (range 1–12). Thus far the median survival time is 4.4 mo, with median time to progression of 2.5 mo. Grade (G) 3/4 febrile neutropenia occurred in 8 out of 18 pts treated at the 75 mg/m 2 dose of docetaxel; none has been seen with the 60 mg/m 2 dose. Other G 3/4 adverse events include: diarrhea (3.8%), rash (7.7%), constitutional symptoms (11.5%), and nausea (11.5%). Conclusion: The combination of gefitinib and docetaxel at 60 mg/m 2 is tolerable, with interim results showing a median survival time of 4.4 mo at this point. If the protocol’s goal of median survival time of 5.25 mo is met upon study completion, the combination may be worthy of further investigation. No significant financial relationships to disclose.
