Completion Rate Of Chemotherapy Research Articles

Neoadjuvant Carboplatin/Paclitaxel versus 5-Fluorouracil/Cisplatin in Combination with Radiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Multicenter Comparative Study

Simple SummaryThe most beneficial neoadjuvant chemoradiotherapy for Asian patients with esophageal squamous cell carcinoma remains uncertain. Using propensity score matching by inverse probability of treatment weighting to balance the baseline variables, the neoadjuvant carboplatin/paclitaxel (CROSS) regimen versus the cisplatin/5-fluorouracil (PF) regimen in combination with 41.4–50.4 Gy of radiotherapy were compared. We found that Taiwanese patients treated with the CROSS regimen (Carboplatin + Paclitaxel + 41.4–45.0 Gy) had less treatment-related complications and more favorable survival figures. Collectively, these results suggest that CROSS is safe and effective.Background: The most beneficial neoadjuvant chemoradiotherapy (nCRT) combination for esophageal squamous cell carcinoma (ESCC) in Asia remains uncertain. Herein, we compared the neoadjuvant carboplatin/paclitaxel (CROSS) regimen versus the cisplatin/5-fluorouracil (PF) regimen in combination with 41.4–50.4 Gy of radiotherapy. Methods: Patients were stratified according to their nCRT regimen: CROSS + 41.4–45.0 Gy (CROSS), PF + 45.0 Gy (PF4500) or PF + 50.4 Gy (PF5040). Propensity score matching by inverse probability of treatment weighting (IPTW) was used to balance the baseline variables. Results: Before IPTW, a total of 334 patients were included. The lowest chemotherapy completion rate was observed in the PF5040 group (76.2% versus 89.4% and 92.0% in the remaining two groups, respectively). Compared with CROSS, both PF groups showed more severe weight loss during nCRT and a higher frequency of post-esophagectomy anastomotic leaks. The use of PF5040 was associated with the highest rate of pathological complete response (45.3%). While CROSS conferred a significant overall survival benefit over PF4500 (hazard ratio [HR] = 1.30, 95% CI = 1.05 to 1.62, p = 0.018), similar survival figures were observed when compared with PF5040 (HR = 1.17, 95% CI = 0.94 to 1.45, p = 0.166). Conclusions: The CROSS regimen conferred a significant survival benefit over PF4500, although the similar survival figures were similar to those observed with PF5040. Considering the lower incidences of severe weight loss and post-esophagectomy anastomotic leaks, CROSS represents a safe and effective neoadjuvant treatment for Taiwanese patients with ESCC.

187: EFFECT OF PERI-OPERATIVE CHEMOTHERAPY REGIMEN ON SURVIVAL IN THE TREATMENT OF LOCALLY ADVANCED GASTRO-OESOPHAGEAL ADENOCARCINOMA—FLOT VS ‘MAGIC’

Abstract Background and aim Peri-operative chemotherapy has been shown to improve survival in patients with locally advanced oesophago-gastric adenocarcinoma. Two commonly used regimens are epirubicin, cisplatin plus capecitabine or fluorouracil (MAGIC) and fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT). The primary aim of this study was to evaluate the effect of chemotherapy regimen (FLOT vs MAGIC) on survival. We also aimed to assess pathological response, surgical complications, chemotherapy associated adverse events and chemotherapy completion rates. Methods Cohort study including 946 patients treated with peri-operative FLOT or MAGIC chemotherapy who underwent oesophagectomy or gastrectomy for oesophageal or gastric adenocarcinoma between 2002–2021 at St Thomas’ Hospital, London, UK or The Royal Marsden Hospital, London, UK. Survival analysis was performed using Kaplan–Meier and Cox regression. Results Patients treated with MAGIC had worse overall and disease-free survival compared with FLOT on multivariable analysis (overall survival HR 1.353 95% CI 1.039–1.763, disease-free survival HR 1.335 95% CI 1.025–1.739). Stratified analysis by tumour location revealed similar results for both oesophageal and gastric tumours. Patients treated with FLOT were more likely to have a favourable pathological response (Mandard 1–2) (11.1% MAGIC vs 21.8% FLOT, P < 0.001). Patients treated with FLOT were less likely to have a positive resection margin (19.1% FLOT vs 32.2% MAGIC, P < 0.001). Surgical complications, chemotherapy associated adverse events and chemotherapy completion rates were comparable between groups. Conclusion Patients with oesophageal and gastric adenocarcinoma treated with peri-operative FLOT had improved survival compared with those treated with peri-operative MAGIC. Surgical complications, chemotherapy associated adverse events and chemotherapy completion rates were comparable between groups. Table https://secure.sem-2000.it/semUpload/OLC/file/9203828791100911681076702/94509_Table.jpg.

A prospective observational study of postoperative adjuvant chemotherapy for non-small cell lung cancer in elderly patients (≥ 75years).

To examine the effects of postoperative adjuvant chemotherapy for elderly (≥ 75years of age) patients with completely resected non-small cell lung cancer (NSCLC), we conducted a multi-institutional and prospective observational study. Patients were recruited between January 2014 and December 2017, and assigned to two cohort groups based on the patients' choice either to receive postoperative adjuvant chemotherapy (Cohort B) or not (Cohort A). All the patients were observed for 2years after enrollment. The primary endpoint was the postoperative change of Karnofsky Performance Status (KPS) at 2years. The secondary endpoints were postoperative recurrence-free survival (RFS) and overall survival (OS) at 2years, and the completion rate of the adjuvant chemotherapy. Two hundred and seventy-two patients were enrolled (Cohort A, n = 225; Cohort B, n = 47). At any time point after surgery, no marked difference of KPS was observed between Cohort B and Cohort A. The RFS at 2years was 70.8% (95% confidence interval [CI], 64.3-76.4) in Cohort A and 76.0% (95% CI 60.8-85.9) in Cohort B. The OS at 2years was 85.9% (95% CI 80.4-89.9) in Cohort A and 89.1% (95% CI 75.8-95.3) in Cohort B. The completion rate of planned chemotherapy was 49.9% (95% CI 34.1-63.9%). The elderly patients were not likely to choose to receive postoperative adjuvant chemotherapy; however, no significant adverse effect on postoperative KPS was identified. Clinical Trial Registration ID: UMIN000020736.

Efficacy of active hexose correlated compound on survival of patients with resectable/borderline resectable pancreatic cancer: a study protocol for a double-blind randomized phase II study

BackgroundThe prognosis of pancreatic ductal adenocarcinoma remains very poor. One possible reason for the short survival of patients with this disease is malnutrition, which can be present at the initial diagnosis, and continue after pancreatectomy. Then, it is important to improve nutritional status and to decrease adverse events during neoadjuvant and adjuvant chemotherapy. Active hexose correlated compound (AHCC) is a standardized extract of cultured Lentinula edodes mycelia, and is considered a potent biological response modifier in the treatment of cancer. To evaluate the survival impact of AHCC on the patients with pancreatic ductal adenocarcinoma, we plan to perform this trial.MethodsThis is a prospective multicenter phase II trial in patients with resectable/borderline resectable pancreatic ductal adenocarcinoma to investigate the efficacy of AHCC regarding survival. Patients will begin taking AHCC or placebo on the first day of neoadjuvant therapy. AHCC or placebo will be continued until 2 years after surgery. The primary endpoint will be 2-year disease-free survival. The secondary endpoints are the completion rate, dose intensity, and adverse event profile of preoperative chemotherapy; response rate to preoperative chemotherapy; rate of decrease in tumor marker (carbohydrate antigen 19-9, carcinoembryonic antigen) concentrations during preoperative chemotherapy; entry rate, completion rate, dose intensity, and adverse event profile of adjuvant chemotherapy; safety of the protocol therapy (adverse effect of AHCC); 2-year overall survival rate; and nutrition score before and after preoperative chemotherapy, and before and after adjuvant chemotherapy. We will enroll 230 patients, and the study involves eight leading Japanese institutions that are all high-volume centers in pancreatic surgery.DiscussionAHCC is expected to function as a supportive food in patients with pancreatic ductal adenocarcinoma, to reduce the proportion of severe adverse events related to neoadjuvant chemotherapy, and to increase the completion proportion of multimodal treatments, resulting in improved survival.Trial registrationThe trial protocol has been registered in the protocol registration system at the Japan Registry of Clinical Trials (Trial ID: jRCTs051200029). At the time of the submission of this paper (October 2020), the protocol version is 2.0. The completion date is estimated to be November 2024.

Effect of Shengbai Decoction on Chemotherapy-Induced Myelosuppression and Survival of Gastric Cancer Patients After Radical Resection: A Retrospective Study.

BackgroundMyelosuppression is one of the most common chemotherapy-induced adverse events and results in a series of clinical symptoms. This study aimed to evaluate the effect of Shengbai decoction (SD) on chemotherapy-induced myelosuppression and survival of gastric cancer (GC) patients after radical resection.Material/MethodsWe retrospectively analyzed data from 115 patients with stage II–III GC who underwent adjuvant chemotherapy after radical resection between May 2015 and June 2017 in our hospital. Among these patients, 57 received Shengbai decoction along with adjuvant chemotherapy (SD group), while 58 received adjuvant chemotherapy alone (control group). Medical records, including adverse events, the treatment completion rate of adjuvant chemotherapy, 3-year overall survival (OS), and 3-year recurrence-free survival (RFS), were compared.ResultsPatient characteristics did not differ significantly between the 2 groups. No adverse events related to Shengbai decoction were reported in the SD group. Patients in the SD group had less neutropenia (P=0.0430), thrombocytopenia (P=0.0323), and anemia (P=0.0497). The SD group had a significantly lower probability of dose reduction (P=0.0448). The completion rate of adjuvant chemotherapy of the SD group was considerably higher than that of the control group (P=0.0398). The SD group had a significantly better 3-year RFS (P=0.0369) and 3-year OS (P=0.0455) than the control group.ConclusionsShengbai decoction effectively improved postoperative survival of patients with GC by alleviating chemotherapy-induced myelosuppression and improving the completion rate of adjuvant chemotherapy.

Systemic Therapy for Resected Pancreatic Adenocarcinoma: How Much is Enough?

Systemic therapy is an essential part of treatment for pancreatic ductal adenocarcinoma (PDAC). However, not all patients receive every cycle of chemotherapy and even if they do, the impact of reduced dose density (DD) on survival is not known. A single institutional prospective database was queried for patients with PDAC who underwent curative resection between 2009 and 2018. The primary outcome was DD, defined as the percentage of total planned chemotherapy actually received and associated survival. Of the 126 patients included, 38.9% underwent a neoadjuvant approach, which was associated with a greater median number of completed chemotherapy cycles (5 cycles versus 4 cycles, p < 0.01) and a higher median total DD (93.0% versus 65.0%, p < 0.01), compared with an adjuvant treatment approach. In both groups, adjuvant chemotherapy completion rates were low, with only 55 patients completing all adjuvant cycles. After sequential survival analysis, patients who received a DD ≥ 80% had improved median overall survival (OS) (27.1 months versus 18.6 months, p = 0.01), compared with patients who achieved a DD < 80%. On multivariate Cox proportional-hazards modeling, only the presence of lymphovascular invasion (HR: 1.77, 95% CI: 1.04-2.99, p = 0.04) and DD < 80% (HR: 1.91, 95% CI: 1.23-3.00, p = 0.01) were associated with decreased OS. In this cohort study, patients who received ≥ 80% DD had significantly better OS. DD should be considered an important prognostic metric in pancreatic cancer, and strategies are needed to improve chemotherapy tolerance to improve patient outcomes.

Effect of peri-operative chemotherapy regimen on survival in the treatment of locally advanced oesophago-gastric adenocarcinoma – A comparison of the FLOT and ‘MAGIC’ regimens

BackgroundPeri-operative chemotherapy improves survival in patients with locally advanced oesophago-gastric adenocarcinoma. Two regimens with proven survival benefits are epirubicin, cisplatin plus capecitabine or fluorouracil (Medical Research Council Adjuvant Gastric Infusional Chemotherapy, MAGIC) and fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT). This study aimed to compare the effect of these regimens on survival (primary aim) and pathological response, surgical complications, adverse events and chemotherapy completion rates. MethodsCohort study including 946 patients treated with FLOT (n = 257) or MAGIC (n = 689) who underwent surgical resection for oesophageal (n = 743) or gastric (n = 203) adenocarcinoma between 2002 and 2021 at St Thomas’ Hospital or The Royal Marsden Hospital, London, UK. Survival analysis was performed using multivariable Cox regression, providing hazard ratios (HRs) with 95% confidence intervals (CIs) adjusted for age, sex, clinical T-stage, clinical N-stage, tumour grade and presence of signet ring cells. ResultsPatients treated with FLOT had better overall survival (HR = 0.69, 95% CI 0.50–0.94) and disease-free survival (HR = 0.75, 95% CI 0.58–0.98) than MAGIC. Patients treated with FLOT were more likely to have a complete pathological response (9.5% FLOT versus 5.5% MAGIC, p = 0.027) and were less likely to have a positive resection margin (19.1% FLOT versus 32.2% MAGIC, p < 0.001). The stratified analysis revealed similar results for oesophageal and gastric tumours. Rates of surgical complications, chemotherapy-associated adverse events and completion were similarly distributed between treatment groups. ConclusionsPatients with oesophageal or gastric adenocarcinoma treated with peri-operative FLOT had better survival and pathological response than those treated with peri-operative MAGIC. Rates of surgical complications, adverse events and chemotherapy completion were comparable.

Clinical and Socioeconomic Factors that Predict Non-completion of Adjuvant Chemotherapy for Colorectal Cancer in a Rural Cancer Center.

Previous literature demonstrates correlations between comorbidities and failure to complete adjuvant chemotherapy. Frailty and socioeconomic disparities have also been implicated in affecting cancer treatment outcomes. This study examines the effect of demographics, comorbidities, frailty, and socioeconomic status on chemotherapy completion rates in colorectal cancer patients. This was an observational case-control study using retrospective data from Stage II and III colorectal cancer patients offered chemotherapy between January 01, 2013 and January 01, 2018. Data was obtained using the cancer registry, supplemented with chart review. Patients were divided based on treatment completion and compared with respect to comorbidities, age, Eastern Cooperative Oncology Group (ECOG) score, and insurance status using univariate and multivariate analyses. 228 patients were identified: 53 Stage II and 175 Stage III. Of these, 24.5% of Stage II and 30.3% of Stage III patients did not complete chemotherapy. Neither ECOG status nor any comorbidity predicted failure to complete treatment. Those failing to complete chemotherapy were older (64.4 vs 60.8 years, P = .043). Additionally, those with public assistance or self-pay were less likely to complete chemotherapy than those with private insurance (P = .049). Both factors (older age/insurance status) remained significant on multivariate analysis (increasing age at diagnosis: OR 1.03, P =.034; public insurance: OR 1.84, P = .07; and self-pay status: OR 4.49, P = .03). No comorbidity was associated with failure to complete therapy, nor was frailty, as assessed by ECOG score. Though frailty was not significant, increasing age was, possibly reflecting negative attitudes toward chemotherapy in older populations. Insurance status also predicted failure to complete treatment, suggesting disparities in access to treatment, affected by socioeconomic factors.

Strategy of Pancreatectomies for Pancreatic Ductal Adenocarcinoma in Patients with a History of Gastrectomy.

Recently, the incidence of pancreatectomy for patients with a history of upper abdominal surgery has been increasing. The clinical courses of 307 patients who underwent the pancreatectomy for pancreatic ductal adenocarcinoma (PDAC) were retrospectively reviewed to clarify the impact of a history of gastrectomy in patients undergoing a pancreatectomy for PDAC. Among 307 patients, 28 (9.1%) had a history of gastrectomy, while 279 did not. We compared the difference in clinical course and prognostic outcomes between the groups. In patients with a history of gastrectomy, the 5-year survival rate was 17.6%, which was relatively poorer than that of patients without it (33.4%, P = 0.1329). A multivariate analysis of factors associated with the overall survival rate identified the low preoperative body mass index [BMI < 20.3 kg/m2, hazard ratio (HR) 1.646, P = 0.0190] and adjuvant chemotherapy (not-completed, HR 1.652, P = 0.0170) as independent prognostic factors. In patients with a history of gastrectomy, there were significantly more patients with poor prognostic factors, including a low preoperative BMI (P = 0.0009) and low completion rate of adjuvant chemotherapy (P = 0.0294) as compared with those without a history of gastrectomy. A low preoperative BMI significantly reduced the completion rate of adjuvant chemotherapy (P = 0.0186), which may lead to poor prognostic outcomes. In conclusion, perioperative nutritional management is important to reduce postoperative BMI loss and obtain a better prognosis after a pancreatectomy for PDAC in patients with a history of gastrectomy.

The impact of systematic assessment for adverse events on unscheduled hospital utilization in patients receiving neoadjuvant or adjuvant chemotherapy: A retrospective multicenter study.

BackgroundThis study was conducted to compare the reported adverse event (AE) profiles and unexpected use of medical services during chemotherapy between before and after the healthcare reimbursement of AE evaluation in patients with cancer.Patients and MethodsUsing the electronic medical record database system, extracted patients with breast, lung, gastric, and colorectal cancers receiving neoadjuvant or adjuvant chemotherapy between September 2013 and December 2016 at four centers in Korea were matched using the 1:1 greedy method: pre‐reimbursement group (n = 1084) and post‐reimbursement group (n = 1084). Unexpected outpatient department (OPD), emergency room (ER) visit, hospitalization rates, and chemotherapy completion rates were compared between the groups.ResultsThe baseline characteristics were well‐balanced between the groups. By chemotherapy cycle, hospitalization (1.8% vs. 2.3%; p = 0.039), and ER visit rates (3.3% vs. 3.9%; p = 0.064) were lower in the post‐reimbursement group than that in the pre‐reimbursement group. In particular, since cycle 2, ER visit and hospitalization rates were significantly lower in the post‐reimbursement group than those in the pre‐reimbursement group (2.6% vs. 3.3%; p = 0.020 and 1.4% vs. 2.0%; p = 0.007, respectively), although no significant differences were observed during cycle 1. The OPD visit rates were similar between both groups, regardless of cycles. The post‐reimbursement group had a higher proportion of patients who completed chemotherapy as planned than the pre‐reimbursement group (93.5% vs. 90.1%; p = 0.006). Post‐reimbursement group had more AEs reported, including alopecia, fatigue, diarrhea, anorexia, and peripheral neuropathy, during cycle 1 than the pre‐reimbursement group, which significantly decreased after cycle 2.ConclusionThe introduction of healthcare reimbursement for AE evaluation may help physicians capture and appropriately manage AEs, consequently, decreasing hospital utilization and increasing chemotherapy completion rates.

CTNI-34. TOXICITY PROFILE AND COMPLIANCE OF PATIENTS WITH HIGH RISK GRADE 2 OR GRADE 3 GLIOMAS RECEIVING ADJUVANT PCV VERSUS ADJUVANT TEMOZOLOMIDE

Abstract INTRODUCTION The NCCN recommends either PCV (Procarbazine, CCNU and vincristine) or Temozolomide (TMZ) as adjuvant therapy in high-risk grade 2 &amp; grade 3 gliomas. In this ongoing study we are comparing PCV with TMZ as adjuvant therapy in this setting. METHODS This is a randomised phase 3 study that includes patients with high risk (as per RTOG) grade 2 gliomas and grade 3 gliomas after surgery. Patient are randomly assigned in 1: 2 to receive either adjuvant PCV or TMZ after adjuvant RT. The primary end-point is progression-free survival &amp; key secondary end points are overall survival, toxicity and quality of life. The current analysis focuses on the compliance and adverse events seen in patients enrolled till 30th April 2020. RESULTS 46 patients were enrolled, with 30 patients in TMZ arm. The median age of patients was 37 years (range 23-64). The ECOG PS was 1 in 45 (97.8%) patients and 2 in 1(2.2%) patient at enrolment. The number of patients who have completed all planned cycles of chemotherapy in the PCV arm is 62.5% (10, n=16) as compared to 90% (27, n=30) in the TMZ arm (P=0.047). The incidence of grade 3 or higher adverse events is 68.8% (n=11) in the PCV arm and 16.7% (n=5) in the TMZ arm (P=0.001). The most common grade 3 or higher toxicities noted are lymphopenia in 50% (n=8), neutropenia in 37.5% (n=6), and thrombocytopenia in 25% (n=4) in the PCV arm; while the corresponding numbers in the TMZ arm are 13.3% (n=4), 3.3% (n=1) and 10% (n=3) respectively. CONCLUSION In the current study the chemotherapy completion rates are higher with TMZ and it is associated with lower grade 3-4 events, whether this will lead to an improvement in outcomes remains to be seen.

A Modified Intraperitoneal Chemotherapy Regimen for Ovarian Cancer: Technique and Treatment Outcomes.

Simple SummaryTo overcome the limitations of intraperitoneal chemotherapy (IP), which include a low completion rate and port-related toxicities, we modified three institutional procedures concerning IP chemotherapy in patients with ovarian cancer: (i) insertion of an IP port in a neutral abdominal position, (ii) daily irrigation of the peritoneal cavity with warmed dextrose fluid (5%) for IP port patency and to prevent adhesion, and (iii) intravenous infusion of cisplatin on Day 2 after left colonic surgery. Among patients who underwent left colonic surgery, including low anterior resection, 27 were investigated to identify the rate of completion of six planned cycles and the feasibility of IP chemotherapy. With modifications in IP chemotherapy, the completion rate improved even after patients underwent left colonic surgery during cytoreduction with enhanced feasibility.This study aimed to investigate treatment outcomes concerning three institutional modifications to intraperitoneal (IP) chemotherapy for patients with ovarian cancer. The medical records of 27 patients treated with IP chemotherapy were retrospectively reviewed. All patients had three IP chemotherapy institutional modifications; modified Gynecologic Oncology Group 172 regimen was used for the chemotherapy regimen. With institutional modifications, 63.0% (17/27) completed all six cycles of IP chemotherapy. Of the 17 and 10 patients with primary and recurrent ovarian cancer, respectively, 55.6% (15/27) underwent left colonic surgery, including low anterior resection. In patients with primary ovarian cancer, the IP chemotherapy completion rate was 76.5% (13/17). In patients with and without left colonic surgery, the IP chemotherapy completion rates were 53.3% (8/15) and 75.0% (9/12), respectively. No complications related to left colonic surgery during IP chemotherapy were identified. The most frequent grade 3–4 toxicities were gastrointestinal toxicities (33.3%) and neutropenia (29.6%). The median progression-free survival was 19.5 months in all patients and 25.2 months in patients with primary ovarian cancer. Three institutional modifications to IP chemotherapy increased the completion rate for planned IP chemotherapy, even after left colonic surgery. Further studies involving a larger study cohort are required to confirm survival outcomes using these modifications.

Survival outcomes associated with completion of adjuvant oxaliplatin-based chemotherapy for stage III colon cancer: A national population-based study.

The impact of cycle completion rates of oxaliplatin-based adjuvant chemotherapy for stage III colon cancer in real-world practice is unknown. We assessed its impact, and that of treatment modification, on 3-year cancer-specific mortality. Four thousand one hundred and forty-seven patients with pathological stage III colon cancer undergoing major resection from 2014 to 2017 in the English National Health Service were included. Chemotherapy data came from linked national administrative datasets. Competing risk regression analysis for 3-year cancer-specific mortality was performed according to completion of <6, 6-11, or 12 5-fluoropyrimidine and oxaliplatin (FOLFOX) cycles, or <4, 4-7, or 8 capecitabine and oxaliplatin (CAPOX) cycles, adjusted for patient, tumour and hospital-level characteristics. Median age was 64 years. Thirty-two per cent of patients had at least one comorbidity. Forty-two per cent of patients had T4 disease, and 40% had N2 disease. Compared to completion of 12 FOLFOX cycles, cancer-specific mortality was higher in patients completing <6cycles [subdistribution hazard ratios (sHR) 2.17; 95% CI 1.56-3.03] or 6-11 cycles (sHR 1.40; 95% CI 1.09-1.78) (P < .001). Compared to completion of 8 CAPOX cycles, cancer-specific mortality was higher in patients completing <4cycles (sHR 2.02; 95% CI 1.53-2.67) or 4-7cycles (sHR 1.63; 95% CI 1.27-2.10) (P < .001). Dose reduction and early oxaliplatin discontinuation did not impact mortality in patients completing all cycles. Completion of all cycles of chemotherapy was associated with improved cancer-specific survival in real-world practice. Poor prognostic factors may have affected findings, however, patients completing <50% of cycles had poor outcomes. Clinicians may wish to facilitate completion with treatment modification in those able to tolerate it.

The Effect Of Exercise On Chemotherapy Completion In Advanced Stage Cancers: The ENACT Trial

Exercise during chemotherapy is safe, feasible, and effective at improving physical and patient-reported outcomes and has been suggested to help improve chemotherapy completion rates. Few trials have reported these clinical outcomes and previous reports have only included one cancer site and mostly early-stage cancers. PURPOSE: To evaluate the effect of exercise on chemotherapy completion rates in advanced stage cancer patients. METHODS: The Exercise in All Chemotherapy (ENACT) trial was a single-arm pragmatic outpatient exercise trial for adults with solid tumors receiving chemotherapy. Seventy-one adults with advanced stage cancer (48F, 58.90 ± 11.20 years, 28 Stage 3) enrolled in ENACT. Patients were given home-based resistance, aerobic, flexibility, and balance exercises. Chemotherapy schedules and dosage changes for Stages 3 and 4 breast (BCa), gastrointestinal (GI), and pancreatic (PCa) cancer patients were obtained via the electronic health record. We also examined the effect of low (<70%) and high (>70%) exercise adherence on relative dose intensities (RDI) and dose delays. RESULTS: RDI differed by cancer sites: BCa (96.15%), GI (75.18%), and PCa (62.00%). BCa had a significantly higher RDI compared to GI (MD = 20.97, SE = 6.44, p = .005) and PCa (MD = 34.15, SE = 7.65, p < .001). Further, BCa patients had less weeks of dose delays (0.46 ± 1.11) compared to GI (1.24 ± 2.57), and PCa (1.19 ± 1.87). Exercise adherence had an effect on RDI and dose delays. BCa patients with low adherence had a RDI of 87.44% compared to 95.97% for high adherence. PCa patients with low adherence also had a lower RDI of 50.38% compared to 63.72% for patients with high adherence. For BCa and PCa patients, a sample size of 186 and 76, respectively, would yield 80% statistical power for detecting the observed differences. BCa patients who exercised more had no dose delays, while those who exercised less had average of 0.98 ± 1.51 weeks of dose delays. GI patients with high exercise adherence had 0.66 ± 1.51 weeks of dose delays compared to 1.68 ± 3.17 weeks for those with low exercise adherence. CONCLUSIONS: We observed that being more physically active resulted in higher RDIs and shorter time to complete chemotherapy. Although our results are not statistically significant, they show promise to the salutary effect of exercise in advanced stage patients.

Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer: The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a randomized clinical trial

BackgroundThe World Cancer Research Fund and the American Cancer Society provide nutrition and physical activity guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines and delay efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse treatment-related side effects and may improve adherence to treatment, resulting in improved breast cancer prognosis. The Lifestyle, Exercise, and Nutrition Early after Diagnosis (LEANer) study is testing the effect of a nutrition and physical activity intervention on chemotherapy completion rates. Methods172 women with stage I-III breast cancer undergoing chemotherapy will be randomized 1:1 to a yearlong, 16 session, nutrition and exercise intervention or usual care control group. The intervention is delivered by registered dietitians specializing in oncology nutrition and exercise training. The intervention includes goal setting to meet nutrition and physical activity guidelines for cancer survivors. After each chemotherapy session, date and dose of each drug administered, and reason for dose-adjustments and/or dose-delays are abstracted from the electronic medical record or obtained from the treating oncologist. Chemotherapy completion rate is assessed as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. Secondary endpoints of endocrine therapy adherence, treatment-related side effects, and changes in inflammatory and metabolic biomarkers, body composition, and patient reported outcomes are assessed at four timepoints. DiscussionIf successful, this study has the potential to make healthy lifestyle interventions a standard component of breast cancer treatment.

Hepatectomy Followed by Adjuvant Chemotherapy with 3-Month Capecitabine Plus Oxaliplatin for Colorectal Cancer Liver Metastases.

Lessons Learned Three‐month adjuvant capecitabine plus oxaliplatin in combination (CAPOX) appeared to reduce recurrence, with mild toxicity in postcurative resection of colorectal cancer liver metastases (CLM).Recurrence in patients who underwent the 3‐month adjuvant CAPOX after resection of CLM was most commonly at extrahepatic sites. BackgroundThe role of neoadjuvant and adjuvant chemotherapy in the management of initially resectable colorectal cancer liver metastases (CLM) is still unclear. We evaluated the feasibility of 3‐month adjuvant treatment with capecitabine plus oxaliplatin in combination (CAPOX) for postcurative resection of CLM.MethodsPatients received one cycle of capecitabine followed by four cycles of CAPOX as adjuvant chemotherapy after curative resection of CLM. Oral capecitabine was given as 1,000 mg/m2 twice daily for 2 weeks in a 3‐week cycle, and CAPOX consisted of oral capecitabine plus oxaliplatin 130 mg/m2 on day 1 in a 3‐week cycle. Primary endpoint was the completion rate of adjuvant chemotherapy. Secondary endpoints included recurrence‐free survival (RFS), overall survival (OS), dose intensity, and safety.ResultsTwenty‐eight patients were enrolled. Median age was 69.5 years, 54% of patients had synchronous metastases, and 29% were bilobar. Mean number of lesions resected was two, and mean size of the largest lesion was 31 mm. Among patients, 20 (71.4%; 95% confidence interval, 53.6%–89.3%) completed the protocol treatment and met its primary endpoint. The most common grade 3 or higher toxicity was neutropenia (29%). Five‐year recurrence‐free survival and overall survival were 65.2% and 87.2%, respectively.ConclusionThree‐month adjuvant treatment with CAPOX is tolerable and might be a promising strategy for postcurative resection of CLM.

Chemotherapy completion rate for locally advanced rectal cancer at a safety-net hospital.

e15597 Background: Patients with locally advanced rectal cancer (LARC) typically receive chemoradiation prior to surgery, followed by adjuvant chemotherapy (standard). Recently there has been a growing trend toward total neoadjuvant therapy (TNT), in which all chemotherapy is given in the neoadjuvant setting, having the advantage of higher chemotherapy completion rates. Data exploring adherence to both standard therapy and TNT within a vulnerable, underserved population is lacking. Within our safety-net hospital, we determined the chemotherapy completion rates for LARC patients who received TNT vs standard treatment. We also compared two populations within the standard treatment group- those who received all doses of prescribed adjuvant chemotherapy (AC) and those who did not. Methods: A retrospective chart review was performed for all patients with LARC (stage II or III) presenting to Los Angeles County + USC Medical Center from 2015 to 2020. Patients who progressed prior to receiving their first dose of chemotherapy and patients lost to follow-up were excluded. Patient demographics, stage, neoadjuvant/adjuvant treatment, operative characteristics, and postoperative course were abstracted. T-tests and Wilcoxon rank-sum tests were used to compare means and medians, respectively; chi-squared tests were used to compare categorical variables. Results: 67 patients were included- 59 in the standard group and 8 in the TNT group. Mean follow-up was 30 months. All patients in the TNT group completed neoadjuvant chemotherapy. In the standard treatment group, the overall AC completion rate was 81% (n = 48) (Complete Group). 19% (n = 11) did not receive all prescribed doses of AC (Incomplete Group). Compared to patients in the Incomplete Group, patients in the Complete Group were significantly older (mean age 55 vs 48, p = 0.017), had a shorter mean time interval from surgery to initiation of AC (9 weeks vs 13 weeks, p = 0.016), and were less likely to experience a delay in receiving AC &gt; 90 days (15% vs 46%, p = 0.022). In total, 12 patients (20%) in the standard group experienced a delay in AC, of which six (50%) were due to anastomotic leak and/or pelvic abscess. Three of those patients who experienced a delay (25%) required either drain placement or re-operation to address their complication. More patients in the Complete Group went on to have their temporary stomas reversed compared to those in the Incomplete Group (94% vs 70%, p = 0.031). Conclusions: While this population had a high AC completion rate, a meaningful proportion of all patients (though more in the Incomplete Group) experienced a delay in AC &gt; 90 days, with surgical complications responsible for the delay in half of these patients. In contrast, all patients who received TNT completed neoadjuvant chemotherapy. TNT may be a reasonable alternative to reduce therapy delays and further improve chemotherapy completion rates in an underserved population.

Our experience of nursing/allied health practitioner led geriatric screening and assessment of older patients with cancer – a highly accessible model of care

ObjectiveComprehensive Geriatric Assessment (CGA) has been proven to assist development of tailored treatment plans for older patients with cancer by identifying health issues affecting their ability to complete systemic therapy or cope with and recover from cancer treatment. Materials and MethodsMetro North Hospital and Health Service (MNHHS) has significant older population with cancer. Geriatric Oncology services were commenced in February 2018 at two facilities of MNHHS [North Lakes Cancer Care Services/Caboolture Hospital (NLCCS/CBH) Cancer services and Redcliffe Hospital (RH) Cancer services]. The Geriatric 8 (G8) screening tool was administered to predict patient vulnerability and need for CGA. A bespoke CGA suite comprising of 16 assessments was used. A clinical nurse or Allied Health (AH) practitioner conducted screening, followed by CGA. Proposed care was discussed at multidisciplinary case conference and AH interventions were provided. ResultsFrom February’2018 to July’2019, the G8 was administered to 1380 patients between the two facilities (918 patients at NLCCS/CBH and 462 patients at RH), comprising oncology and haematology patients. 825 patients (59%) showed impairment on G8 and were recommended for CGA. Another 50 patients were referred for CGA as per clinical assessment despite normal G8. 65% (572) of recommended CGAs were conducted.The most common impairments identified on CGA leading to AH referrals were timed up & go >13 s, malnutrition, polypharmacy and low mood & depression. ConclusionThe nursing/AH practitioner led Geriatric Oncology service is feasible, applicable and beneficial to patients. Further study is planned to assess the impact of the service on patients' health related quality of life and chemotherapy completion rates.

Comprehensive TCM treatments combined with chemotherapy for advanced non-small cell lung cancer: A randomized, controlled trial.

Objective:We conducted this study to evaluate the efficacy and safety of traditional Chinese medicine (TCM) in advanced non-small cell lung cancer (NSCLC) patients who underwent chemotherapy.Design:This was a prospective, open-label, randomized controlled trial. NSCLC patients at stage IIIA, IIIB, or IV were randomly assigned to either TCM plus chemotherapy or chemotherapy alone. The comprehensive TCM treatment consisted of Kang Ai injection, herbal decoction, and Zhenqifuzheng capsules. The primary endpoint was quality of life (QOL) measured by the Functional Assessment of Cancer Therapy-Lung version 4.0. The secondary endpoints were chemotherapy completion rate, tumor response, and adverse events. All assessments were done at baseline, the third week, and the sixth week.Results:Thirty-nine participants were randomly assigned to the treatment group and 36 to the control group. The QOL scores were significantly improved in the treatment group compared with those of the control group in social well-being (cycle 1, P = .048; cycle 2, P = .015), emotional well-being (cycle 1, P = .047; cycle 2, P = 4.29E-05), and functional well-being (cycle 1, P = .030; cycle 2, P = .003), while the QOL scores in the above 3 domains declined in the control group (P < .05). Both groups had a decline in the physical well-being score (cycle 1, P = .042; cycle 2, P = .017) and lung cancer symptom score (cycle 1, P = .001; cycle 2, P = .001) after 2 courses of intervention. The deterioration in physical well-being and lung cancer symptoms was noticeably smaller in the treatment group (P < .05). There were significant differences between the 2 groups in social well-being, emotional well-being, functional well-being, lung cancer symptom domain, and the total score (P < .05). Patients in the treatment group had a significantly lower incidence of platelet reduction than the control group (P = .028) after 2 cycles of treatment. No significant difference in nonhematological adverse events (AEs) was observed.Conclusion:This study illustrated that comprehensive TCM treatment could promote the QOL of NSCLC patients, alleviate symptoms, and reduce the AEs caused by chemotherapy, verifying the synergistic and attenuating effects of TCM in NSCLC patients undergoing chemotherapy.Trial registration:Chinese Clinical Trial Registry (www.chictr.org.cn): ChiCTR-TRC-13003637

Adjuvant tegafur-uracil (UFT) or S-1 monotherapy for advanced gastric cancer: a single center experience

BackgroundAdjuvant tegafur-gimeracil-oteracil (S-1) is commonly used for gastric cancer in Asia, and tegafur-uracil (UFT) is another oral fluoropyrimidine when S-1 is unavailable. The real-world data of adjuvant UFT has less been investigated.MethodsPatients with pathological stage II-IIIB (except T1) gastric cancer receiving adjuvant UFT or S-1 monotherapy after D2 gastrectomy were included. Usage of UFT or S-1 was based on reimbursement policy of the Taiwanese healthcare system. The characteristics, chemotherapy completion rates, and 5-year recurrence-free survival (RFS) and overall survival (OS), were compared between these two groups.ResultsFrom 2005 to 2016, 86 eligible patients were included. Most tumor characteristics were similar between the UFT group (n = 37; age 59.1 ± 13.9 years) and S-1 group (n = 49; age 56.3 ± 10.7 years), except there were significantly more Borrmann type III/IV (86.5% versus 67.3%; p = 0.047) and T4 (56.8% versus 10.2%; p < 0.001) lesions in the UFT group than in the S-1 group. The chemotherapy complete rates were similar in the two groups. The 5-year RFS was 56.1% in the UFT group and 59.6% in the S-1 group (p = 0.71), and the 5-year OS was 78.3% in the UFT group and 73.1% in the S-1 group (p = 0.48). The hazard ratio of adjuvant chemotherapy (S-1 versus UFT) on RFS was 1.25 (95% confidence interval = 0.53-2.94) when Borrmann type and T and N stages were adjusted.ConclusionsThis small cohort study showed adjuvant UFT, and S-1 monotherapy had a comparable long-term outcome for pathological stage II-IIIB gastric cancer following D2 gastrectomy.