Compliance Of Adjuvant Chemotherapy Research Articles

Robot-assisted versus laparoscopic-assisted gastrectomy among malnourished patients with gastric cancer based on textbook outcome.

Textbook outcome (TO) has been widely employed as a comprehensive indicator to assess the short-term prognosis of patients with cancer. Preoperative malnutrition is a potential risk factor for adverse surgical outcomes in patients with gastric cancer (GC). This study aimed to compare the TO between robotic-assisted gastrectomy (RAG) and laparoscopic-assisted gastrectomy (LAG) in malnourished patients with GC. According to the diagnostic consensus of malnutrition proposed by Global Leadership Initiative on Malnutrition (GLIM) and Nutrition Risk Index (NRI), 895 malnourished patients with GC who underwent RAG (n = 115) or LAG (n = 780) at a tertiary referral hospital between January 2016 and May 2021 were included in the propensity score matching (PSM, 1:2) analysis. After PSM, no significant differences in clinicopathological characteristics were observed between the RAG (n = 97) and LAG (n = 194) groups. The RAG group had significantly higher operative time and lymph nodes harvested, as well as significantly lower blood loss and hospital stay time compared to the LAG group. More patients in the RAG achieved TO. Logistic regression analysis revealed that RAG was an independent protective factor for achieving TO. There were more adjuvant chemotherapy (AC) cycles in the RAG group than in the LAG group. After one year of surgery, a higher percentage of patients (36.7% vs. 22.8%; P < 0.05) in the RAG group recovered from malnutrition compared to the LAG group. For malnourished patients with GC, RAG performed by experienced surgeons can achieved a higher rate of TO than those of LAG, which directly contributed to better AC compliance and a faster restoration of nutritional status.

A national evaluation of adjuvant chemotherapy in pT4N0M0 colon cancer from the National Cancer Database.

T stage is a prognostic biomarker for overall survival in colon cancer and pathologic T4 disease is a high-risk characteristic. Adjuvant chemotherapy is recommended to improve overall survival in pT4N0M0, but compliance with guidelines is unknown. We aimed to evaluate adjuvant chemotherapy use and impact on overall survival in pT4N0M0 colon cancer. The National Cancer Database was reviewed for pT4N0M0 colon adenocarcinomas undergoing curative surgical resection (2010-2017). Cases were stratified into no adjuvant chemotherapy and adjuvant chemotherapy cohorts. Moderated multiple regression assessed factors associated with no AC. Kaplan-Meier and Cox regression assessed overall survival in propensity-score matched cohorts. The main outcome measures were adjuvant chemotherapy use, factors associated with adjuvant chemotherapy, and impact on overall survival. Of 11 847 cases, 62.4% (n = 7391) received no adjuvant chemotherapy. With private insurance, comorbidities or income do not affect adjuvant chemotherapy use. Medicare cases with a Charlson-Deyo comorbidity index of 0 (odds ratio [OR] = 0.861, 95% confidence interval [CI] = 0.760 to 0.975; P = .019) and Medicare payors with high income (OR = 0.813, 95% CI = 0.690 to 0.959; P = .014) were associated with adjuvant chemotherapy. Medicaid Charlson-Deyo comorbidity index 0 (OR = 1.374, 95% CI = 1.125 to 1.679; P = .002) and uninsured Charlson-Deyo comorbidity index 0 (OR = 1.351, 95% CI = 1.120 to 1.629; P = .002) were associated with no adjuvant chemotherapy. Adjuvant chemotherapy was associated with improved 5-year overall survival (71.7% vs 56.4%; P < .001; adjusted hazard ratio = 0.543, 95% CI = 0.499 to 0.590; P < .001). Although adjuvant chemotherapy is associated with improved overall survival, compliance is low. There is a complex relationship between payor, income, comorbidity, and adjuvant chemotherapy receipt. Medicare patients with no comorbidities or higher income have better adjuvant chemotherapy use. With private insurance, adjuvant chemotherapy compliance is not affected by comorbidities or income, whereas Medicaid and uninsured patients with no comorbidities have poor compliance. Future work could target these disparities for equitable care.

Effect of malnutrition as defined by the Global Leadership Initiative on Malnutrition criteria on compliance of adjuvant chemotherapy and relapse-free survival for advanced gastric cancer

ObjectivesThe aim of the present study was to clarify the effect of malnutrition as defined by the Global Leadership Initiative on Malnutrition (GLIM) criteria on compliance with postoperative adjuvant chemotherapy and relapse-free survival (RFS) in patients with gastric cancer. MethodsThis single-center, retrospective cohort study included 281 consecutive patients with gastric cancer who underwent radical gastrectomy for pathologic stages II and III and received postoperative S-1 adjuvant chemotherapy between April 2008 and June 2018. Treatment failure was defined as discontinuation of adjuvant chemotherapy ≤1 y. Nutritional assessment was preoperatively performed according to the GLIM criteria for all patients. We analyzed risk factors for treatment failure and poor prognostic factors for RFS using multivariate analyses. ResultsTreatment failure and recurrence were observed in 50 (17.8%) and 97 (34.5%) of the 281 patients, respectively. The median follow-up period was 52 mo. The treatment failure rate was higher (P = 0.032) and RFS was worse (P = 0.017) in the malnutrition group. In multivariate analyses, GLIM criteria–defined malnutrition was an independent risk factor for treatment failure (odds ratio = 3.110; 95% confidence interval [CI], 1.020–9.470; P = 0.046). Furthermore, severe malnutrition was an independent poor prognostic factor for RFS (hazard ratio = 1.767; 95% CI, 1.132–2.759; P = 0.012). ConclusionsPreoperative malnutrition as defined by the GLIM criteria was an independent risk factor for poor compliance with adjuvant S-1 chemotherapy and a poor prognostic factor for RFS after radical gastrectomy in patients with advanced gastric cancer.

A national evaluation of the predictors of compliance and survival from adjuvant chemotherapy in high-risk stage II colon cancer: A National Cancer Database (NCDB) analysis

BackgroundGuidelines recommend adjuvant chemotherapy for stage II colon cancer with high-risk features, but there has been little study on compliance with guidelines. This work sought to evaluate compliance with adjuvant chemotherapy and factors associated with compliance in high-risk stage II colon cancer. This work’s hypothesis was that compliance with adjuvant chemotherapy recommendations is low, but improves overall survival when used. MethodsThe National Cancer Database was reviewed for stage II high-risk colon cancers that underwent curative resection from 2010 to 2017. The cases were stratified into adjuvant chemotherapy and no adjuvant chemotherapy cohorts. A multivariate logistic regression identified factors associated with adjuvant chemotherapy compliance. Propensity-score matching was performed to balance the cohorts and Kaplan-Meier analysis assessed overall survival. The main outcome measures were adjuvant chemotherapy compliance, factors associated with compliance, and overall survival in high-risk stage II colon cancer. ResultsA total of 52,609 patients were evaluated, and 23.2% received adjuvant chemotherapy. The factors associated with noncompliance included older age (odds ratio 0.919; 95% confidence interval 0.915–0.922; P < .001), Medicaid (odds ratio 0.720; 95% confidence interval 0.623–0.832; P < .001) payor, greater comorbidities (odds ratio 0.423; 95% confidence interval 0.334–0.530; P < .001), and residing in the Midwest (odds ratio 0.898; 95% confidence interval 0.812–0.994; P = .037). All of the known high-risk features were significantly independently associated with compliance. In a matched cohort, adjuvant chemotherapy significantly improved the 5-year overall survival (78.1% vs 66.6%; P < .001). ConclusionNationally, there is low compliance with adjuvant chemotherapy in high-risk stage II colon cancer. Despite the low compliance, adjuvant chemotherapy was associated with improved overall survival. Demographic variables were associated with poor compliance, whereas tumor factors were associated with increased compliance. These results highlighted the disparities in care and opportunities to improve outcomes in high-risk stage II colon cancer.

Reciprocity between lymphadenectomy quality and adjuvant chemotherapy compliance in gastric cancer: post hoc analysis of two randomized controlled trials.

To investigate the effect of intraoperative lymph node (LN) dissection and postoperative adjuvant chemotherapy on the overall survival (OS) of gastric cancer (GC) patients and their reciprocity. LN noncompliance was defined as the absence of more than one LN station, as described in the protocol for D2 lymphadenectomy in the Japanese Gastric Cancer Association. The definition of adjuvant chemotherapy (AC) noncompliance was that the chemotherapy planned dose does not meet the requirements. Kaplan-Meier survival curves showed that the OS of patients with major LN noncompliance was significantly lower than that of patients with nonmajor LN noncompliance, and the OS of AC noncompliance patients was significantly lower than that of AC compliance patients. If there was nonmajor LN noncompliance during surgery, the OS of patients with AC compliance was significantly higher than that of patients with AC noncompliance (P = 0.035). In the case of major LN noncompliance during surgery, there was no statistically significant difference in OS between those with AC compliance and those with AC noncompliance (P = 0.682). Multivariate Cox regression analysis including AC noncompliance indicated that major LN noncompliance was an independent prognostic factor for poor OS (P = 0.012), while AC noncompliance was not an independent prognostic factor for OS (P = 0.609). Adequate lymph node dissection and adjuvant chemotherapy are both key steps to improve the awful prognosis of GC patients. Adjuvant chemotherapy may fail to remedy the poor prognosis caused by major LN noncompliance.

Impact of low visceral fat mass on compliance of adjuvant chemotherapy and relapse-free survival after gastrectomy in gastric cancer patients

Rationale: It has been reported that preoperative reduced skeletal muscle mass and skeletal muscle mass loss during adjuvant chemotherapy are associated with discontinuation of adjuvant chemotherapy. However, the relationship between visceral fat mass and compliance has not yet been investigated. In this study, we investigated the impact of low preoperative visceral fat mass on compliance and relapse-free survival (RFS) after gastrectomy in gastric cancer patients.

Impact of visceral adipose tissue on compliance of adjuvant chemotherapy and relapse-free survival after gastrectomy for gastric cancer: A propensity score matching analysis

It has been reported that skeletal muscle mass loss during adjuvant chemotherapy and preoperative reduced skeletal muscle mass are associated with discontinuation of adjuvant chemotherapy. However, the relationship between visceral fat mass and compliance has not yet been investigated. In this study, we clarified the impact of low preoperative visceral fat mass on compliance and relapse-free survival (RFS) in gastric cancer patients. This was a retrospective cohort study of consecutive patients with gastric cancer who underwent radical gastrectomy for pathological stages II and III, and who received postoperative S-1 adjuvant chemotherapy between April 2008 and April 2017. Treatment failure was defined as discontinuation of adjuvant chemotherapy within 1 year. Visceral fat mass was measured preoperatively at the umbilical level on computed tomography, which was divided by height (m2) to obtain the visceral adipose tissue index (VAI). Patients with a VAI below the median cut-off value were categorized as low-VAI, while those above the cut-off value were classified as high-VAI. We compared the treatment failure rate and RFS in the low-VAI and high-VAI groups after adjusting for group differences with propensity score matching. In addition, risk factors related to treatment failure and poor prognostic factors for RFS were analyzed in multivariate analyses that included all cases. Among all 263 patients, treatment failure and recurrence were observed in 44 patients (16.7%) and 90 patients (34.2%), respectively. The median follow-up period was 52 months. After propensity matching, there were 101 patients in both low -and high-VAI groups. Treatment failure rate was higher (P=0.037) and RFS was worse (P=0.025) in the low-VAI group. In multivariate analyses, low-VAI was an independent risk factor associated with treatment failure (odds ratio (OR): 2.360, 95% CI: 1.120-5.000, P=0.025), and was a poor prognostic factor for RFS (hazards ratio (HR):1.652, 95% CI: 1.057-2.582, P=0.028). Preoperative low visceral fat mass was an independent risk factor for poor compliance with adjuvant chemotherapy and a poor prognostic factor for RFS after radical gastrectomy in gastric cancer patients. Preoperative evaluation using body composition may be useful for post-treatment and prognosis prediction.

Is BMI a Factor in Compliance to Adjuvant Chemotherapy for Locally Advanced Rectal Cancer?

Background: Compliance to adjuvant chemotherapy (AC) for patients undergoing rectal surgery ranges from 43% to 73.6%. Reasons reported for not initiating or completing AC include onset of postoperative complications, drug toxicity, disease progression and/or patient preferences. Little is known regarding the impact of obesity on the compliance to AC in this setting. Methods: This multicenter, retrospective study analyzed compliance to AC and treatment-related morbidity in 511 patients having undergone surgery with curative intent for rectal cancer in six Italian colorectal centers between January 2013 and December 2017. Results: 70 patients were obese (BMI 30 kg/m2). The proportion of open procedures (22.9% vs. 13.4%) and conversions (14.3% vs. 4.8%) was greater in obese compared to non-obese patients (p 0.001). Median hospital stay was one day longer for obese patients (9 days vs. 10 days, p=0.038) while there was no statistically significant difference in the complication rate, whether overall (58.6% in obese vs. 52.3% in non-obese) or with a Clavien-Dindo score 3 (17.1% vs 10.9%). AC was offered to 49/70 (70%) patients in the obese group and 306/441 (69.4%) in the non-obese group (p=0.43). There was no statistically significant difference in AC compliance: 18.4% and 22.9% did not start AC, while 36.7% and 34.6%, started AC but did not complete the scheduled treatment (p=0.79) in the obese and non-obese group, respectively. Overall, 55% of patients who started AC successfully completed their adjuvant treatment. Conclusions: Obesity did not impact compliance to AC for locally advanced rectal cancer: compliance was poor in obese and non-obese patients with no statistically significant difference between the two groups. Major complication rate was not statistically significantly affected by increased BMI.

P-60 Tolerability of adjuvant chemotherapy with TS-1 or XELOX regimen in elderly patients with stage II or III gastric cancer after D2 gastrectomy

Compared to surgery, adjuvant TS-1 and XELOX regimen in gastric cancer (GC) has shown survival benefit after D2 gastrectomy. As the elderly population continues to grow, adjuvant chemotherapy (AC) has become important. Clinicians hesitate to offer chemotherapy to elderly patients because of comorbidities and intolerability. This study aims to investigate the efficacy, safety, and compliance of AC with TS-1 and XELOX regimen in patients aged >70 years.

A phase II study to examine the effectiveness of nutritional support with elemental diet for stage II/III gastric cancer patients receiving adjuvant chemotherapy with S-1 (OGSG 1108).

98 Background: Postoperative weight loss after gastrectomy causes deterioration in patient’s quality of life and tolerance for adjuvant chemotherapy in gastric cancer patients. Nutritional support may prevent postoperative weight loss and chemotherapy related adverse effects to improve compliance of adjuvant chemotherapy. Methods: Clinical stage II/III gastric cancer patients received R0 resection were registered in the first stage of the present study. Those patients were qualified and enrolled in the second stage who could intake more than 60% of elemental diet (Elental, 300 kcal/day for 14 days) in the postoperative period and were proven pathological stage II/III. Enrolled patients were planned to receive a total of 300 kcal/day of Elental for 24 weeks and additional courses was permitted up to 365 days. The primary endpoint was compliance of S-1: percent of patients who accomplish S-1 adjuvant for one year with more than 70% relative performance (RP). The secondary endpoints were nutritional parameters (body weight, BMI, s-albumin, s-protein, s-cholesterol), RP of 8 courses of S-1, adverse effects of S-1, RP of Elental and ratio of patients who were enrolled to the second stage. Results: From January 2012 to September 2014, 149 patients were registered in the first stage and 82 patients were enrolled in the second stage: including 50 men; 32 women; median age of 70 years (range, 42-85 years); and performance status were zero in 45 and one in 37 patients. Compliances of S-1 were 60.5% (95%CI: 49.0, 71.2) in 81 eligible patients and 69% (95%CI: 56.9, 79.5) in eligible patients without recurrence. In 81 eligible patients, RP of 8 courses of S-1 was 87.3 % (95%CI: 88.3, 85.9), and the body weight loss was 1.80kg (95%CI: -0.38, 4.48). Grade 3-4 toxicities were neutropenia 12%, anemia 4%, anorexia 4% and diarrhea 4%. Conclusions: Nutritional support for gastric cancer patients receiving adjuvant chemotherapy contributes to increase compliance of S-1 and potential effect on survival may be expected. Clinical trial information: UMIN000006872.

Changes of weight and body composition after gastrectomy in the elderly gastric cancer patients.

89 Background: Body weight, especially lean body mass, significantly reduces after gastrectomy for gastric cancer due to surgical invasion, reduced food intake, or decreased mobility, which could decrease quality of life and toxicity / compliance of adjuvant chemotherapy. These risks might be high especially in the elderly gastric cancer patients. However, it remains unclear whether changes of weight and body composition are different between the elderly and the non-elderly. Methods: This retrospective study examined patients who underwent curative surgery for gastric cancer between June 2010 and March 2014. Body weight and composition were evaluated by a bioelectrical impedance analyzer within 1 week before surgery (first measurement), at 1 week after surgery (second measurement), at 1 month after surgery (third measurement), and at 3 months after surgery (forth measurement). Patients were classified to the elderly (&gt; 75 years) and the non-elderly ( &lt; 75 years). Results: Four-hundred forty three patients (100 for the elderly and 343 for the non-elderly) were entered in the present study. Patients backgrounds, surgical factors, clinicopathological factors, surgical complications and adjuvant chemotherapy were not significantly different between the two groups. %Body weight loss until 1week, 1month, 3 months after surgery, defined as the proportion of the difference between 1st measurement and each measurement after surgery against 1st measurement, was 3.3%, 6.6%, and 9.7%, respectively in the elderly and 3.7%, 5.4%, and 8.2%, respectively in the non-elderly with significant difference (p = 0.05, 0.01, and 0.01, respectively). %Lean body mass loss until 1 week, 1 month, 3 months after surgery was 3.2%, 5.6%, and 6.1%, respectively in the elderly and 3.2%, 4.5%, and 4.2%, respectively in the non-elderly with p value of 0.36, 0.08, and 0.01, respectively. %Fat loss was not significantly different between the two groups at any time. Conclusions: Decreases in body weight and lean body mass after gastrectomy were more serious in the elderly patients as compared with the non-elderly. Surgical indication for the elderly must be carefully determined considering the risk and the benefit.

Risk factors for loss of lean body mass after gastrectomy for gastric cancer.

79 Background: Lean body mass loss after surgery, which decreases compliance of adjuvant chemotherapy, is frequently observed in gastric cancer patients who underwent gastrectomy for gastric cancer. However, the risk factors of lean body mass loss remain unclear. Methods: The present study retrospectively examined the patients who underwent curative gastrectomy for gastric cancer between June 2010 and March 2014 at Kanagawa Cancer Center. All patients received perioperative care of the enhanced recovery after surgery protocol. % Lean body mass loss was calculated by percentile of lean body mass at one month after surgery to preoperative lean body mass. Severe lean body mass loss was defined as % lean body mass loss over 5%. Risk factors for severe lean body mass loss were determined by both univariate and multivariate logistic regression analyses. Results: Four-hundred eighty five patients were examined. Median age was 67 years. Operative procedure was total gastrectomy in 190 patients and distal gastrectomy in 295 patients. Surgical complications of grade 2 or more defined by Clavien-Dindo classification was observed in 78 patients including pancreatic fistula in 19, anastomotic leakage in 11 and abdominal abscess in 7. Mortality was observed in one patient. Both univariate and multivariate logistic analyses demonstrated that surgical complications (odds rate 3.576, p = 0.001), total gastrectomy (odds rate 2.522, p = 0.0001), and gender (odds rate 1.928, p = 0.001) were significant independent risk factors for severe lean body mass loss. Conclusions: Male, surgical complications, and total gastrectomy were significant risk factors for 5% of lean body mass loss at first month after gastrectomy. To maintain lean body mass after gastrectomy, the physician need careful attention for the patients who had these risk factors.

Effects of perioperative enteral EPA-enriched immunonutrition on meaningful loss of lean body mass after total gastrectomy for gastric cancer: Post hoc analysis of a phase III study.

85 Background: Total gastrectomy for gastric cancer significantly reduces body weight, especially lean body mass (LBM), through surgical stress and decrease of the calorie intake. Eicosapentaenoic acid (EPA)-enriched enteral nutrition (EPA-EN) could modulate immune function and limits catabolism. In our phase III study to compare perioperative standard diet with or without EPA-EN, additional EPA-EN did not contribute to prevent weight loss or LBM. Recently, 5% or more LBM loss after surgery was reported to impair compliance of post-operative S-1 adjuvant chemotherapy. This post hoc study explored whether additional EPA-EN prevented meaningful loss of LBM for compliance of adjuvant chemotherapy after surgery. Methods: Key entry criteria of this phase III study was (1) histologically proven adenocarcinoma of the stomach, (2) clinical T1-T4a and M0, (3) R0 resection is possible by total gastrectomy, (4) sufficient oral intake, and (5) sufficient organ function. The patients were randomized to Group A: no supplementation with oral nutrients (standard diet) or Group B: standard diet with oral supplementation of ProSure including 600 kcal with 2.2 g EPA for 7 days before surgery and for 21 days after surgery. For both groups, patients underwent total gastrectomy with Roux-en Y reconstruction. Results: A total of 127 patients (Group A: 63, Group B: 64) were enrolled in the study. All background factors were well balanced between the both groups. Median relative performance of supplement in group B was 100% before surgery and 54% after surgery. 5% or more LBM loss at 1 month after surgery was observed in 44 patients (80.0%) in group A and in 37 patients (67.3%) in group B (p = 0.194), while that at 3 months after surgery was found in 51 patients (91.1%) in group A and in 43 patients (76.8%) in group B (p = 0.070). Conclusions: Perioperative standard diet with EPA-enriched enteral nutrition tended to prevent meaningful loss of LBM after total gastrectomy. Further analysis is required whether perioperative EPA enriched EN improve compliance of S-1 adjuvant chemotherapy after total gastrectomy. Clinical trial information: UMIN000006380.

Adjuvant Chemotherapy Compliance Is Not Superior After Thoracoscopic Lobectomy

It is generally assumed that patient compliance with adjuvant chemotherapy is superior after video-assisted thoracoscopic surgery compared with open lobectomy for non-small cell lung cancer (NSCLC). The level of evidence for this assumption, however, is limited to single-institution, case-control studies. We used a complete national lung cancer registry. For better comparison and reduction of selection bias, we analyzed only patients who underwent standard lobectomy for clinical stage 1 NSCLC and subsequently had unsuspected lymph node metastases discovered at final histopathology. A clinical oncologist, who was blinded to the surgical approach, reviewed all medical oncology charts for types of adjuvant chemotherapy, reasons for not initiating or stopping treatment, number of cycles delivered, and time interval from surgery to initial chemotherapy. During a 6-year period (2007 to 2012), 1,968 patients underwent standard lobectomy for clinical stage 1 NSCLC by video-assisted thoracoscopic surgery (n=990; 50.3%) or thoracotomy (n=978; 49.7%). Unsuspected nodal upstaging was later found in 341 patients (17.3%), and 313 were analyzed: 189 patients (60.4%) received adjuvant chemotherapy and 121 (38.7%) completed all four cycles. Ordinal logistic regression revealed that chemotherapy compliance (none, partial, and full chemotherapy) was significantly reduced by the patient's age (p<0.001) and comorbidity index (p=0.003) but increased with N2 status (p=0.02). No significant difference between video-assisted thoracoscopic surgery and thoracotomy was seen regarding chemotherapy compliance (p=0.17), number of chemotherapy cycles (p=0.60), or time from surgery to chemotherapy (p = 0.41). Complete national data do not support the widespread assumption that adjuvant chemotherapy compliance is superior after thoracoscopic lobectomy for NSCLC. Instead, significant predictors of chemotherapy compliance are patient's age, comorbidity, and pathologic N status.

Prognostic Factors of Pathologic Stage IB Non-small Cell Lung Cancer

In pathologic IB (pIB) non-small cell lung cancer, especially in adenocarcinoma, adjuvant chemotherapy with uracil-tegafur is widely recognized as being effective. The aim of this study was to determine the prognostic factors of pIB disease. Sixty patients who were diagnosed with pIB disease between 2004 and 2007 were retrospectively analyzed. Of 60 patients, 22 (36.7%) opted for surgery plus adjuvant chemotherapy with uracil-tegafur, whereas 38 (63.3%) opted for surgery only. The oral administration dose of uracil-tegafur was 400 mg/body. Compliance of adjuvant chemotherapy with uracil-tegafur was 65.5% in 12 months, 57.3% in 24 months. Adjuvant chemotherapy was interrupted in 11 patients because of the recurrence of disease in 3 patients and adverse reaction in 8 patients. Anorexia was the most common adverse reaction. The larger tumor diameter (5 cm<) and p2 pleural invasion were the worse prognostic factors in disease free survival in a univariate analysis and a multivariate analysis (hazard ratio = 0.26 and 0.25; p = 0.028 and 0.032, respectively). The prognosis of the patients with pleural invasion and a tumor diameter >5 cm was poor, and these, partly support the forthcoming classification.

Evaluation of the Safety and Compliance of 3-Week Cycles of Vinorelbine on Days 1 and 8 and Cisplatin on Day 1 as Adjuvant Chemotherapy in Japanese Patients with Completely Resected Pathological Stage IB to IIIA Non-small Cell Lung Cancer: A Retrospective Study

With regard to adjuvant chemotherapy for non-small-cell lung cancer, the usefulness of combined chemotherapy with cisplatin (CDDP) and vinorelbine (VNR) has been reported. However, poor compliance has been reported with VNR administered weekly by the conventional method for 16 consecutive weeks, and there is no report on the safety and compliance of adjuvant chemotherapy with CDDP and VNR in Japanese patients. The subjects were 25 non-small-cell lung cancer patients who received CDDP and VNR as adjuvant chemotherapy at the Shizuoka Cancer Center between April 2005 and April 2008. The treatment schedule included combined treatment, with CDDP at 80 mg/m(2) administered on Day 1 and VNR at 25 mg/m(2) administered on Days 1 and 8. The treatment was repeated every 3 weeks, and each 3-week treatment schedule was designated as one cycle. A total of four cycles were administered. The main adverse events were Grade 3 or more severe neutropenia (76%), anemia (12%), anorexia (12%) and nausea (12%). Thus, the adverse events were mostly mild. There were no treatment-related deaths. The rate of completion of the four cycles was 92%. The mean dose of CDDP and VNR was 312 and 195 mg/m(2), respectively. The mean dose administered of either drug was 97.5% of the scheduled dose. This study was retrospective and had some limitations, for example, non-hematological toxicity would be evaluated milder. However, it was considered that adjuvant chemotherapy with CDDP administered on Day 1 and VNR administered on Days 1 and 8 every 3 weeks was safe, and that the rate of completion of the four cycles was also satisfactory in Japanese patients.

PD5-3-6: Compliance with adjuvant chemotherapy for completely resected non-small cell lung cancer

study. The median age of the study group was 60.9 years and 76.7 % of the patients enrolled were male. 34.9%, 28.8% and 36.2% of the patients were in stage IB, II and III respectively. In addition, 142 of the patients (61.2%) completed all planned cycles, whereas 65 patients (28%) received no therapy. The causes of start failure for adjuvant chemotherapy consisted of decreased postoperative performance status (n=39), refusal (n=13) and distant metastasis at the initial follow-up (n=2). The causes of cessation during adjuvant chemotherapy included the occurrence of severe adverse effects (n=12), aggravation of the disease with newly developed metastasis (n=4) and others (n=6). The mortality related to the adjuvant chemotherapy was 1.3 % (n=3), all of the fatalities were due to pneumonia and sepsis. Univariate analysis showed that age, postoperative complications and pathologic staging were the significant factors that determined whether the adjuvant chemotherapy was completed. Multivariate analysis demonstrated statistically significant differences in compliance when age and pathologic staging were considered. Conclusion: Adjuvant chemotherapy for completely resected NSCLC was performed with satisfactory compliance in approximately 60% of the patients included in this study, and age plays an important role in the compliance of adjuvant chemotherapy. Elderly subsets will be examined to help determine the effect of age on compliance and outcome. In addition, the medical oncologist tended to complete the adjuvant chemotherapy for more advanced cases of lung cancer than for stage IB lung cancer.

Feasibility of adjuvant carboplatin/docetaxel (C/D) in patients (pts) resected stage I-IIIB non-small cell lung cancer (NSCLC): Preliminary report of a phase II trial

18069 Background: Adjuvant cisplatin-based chemotherapy has been shown to improve survival in patients with resected NSCLC; however, compliance with chemotherapy has been problematic. Carboplatin (C) is better tolerated than cisplatin, and therefore may improve adjuvant chemotherapy compliance. C/D is a commonly used treatment for advanced NSCLC with an acceptable toxicity profile. Methods: Pts with resected NSCLC with a good functional status, preserved renal, hepatic, and bone marrow function were enrolled. Therapy was initiated 2–8 weeks from surgery, and consisted of 4 cycles C (AUC=6), and docetaxel (D) 75 mg/m2 every 3 weeks. The primary end-point was the feasibility of delivering C/D. An “adequate exposure” was defined as receiving 4 cycles of C/D within 12 weeks of initiating therapy. A sample size of 72 pts provided 88% power to detect a true adequate exposure of rate of at least 80%. Results: 72 pts have been enrolled on the protocol, and 64 patients have completed therapy, 7 patients are currently receiving therapy, and data is incomplete on 1 patient. Pt demographics are: median age=65 years (range 47–84); gender: female 34%, male 66%, race: white 86%, African American 10%, other minorities 4%; performance status: 0 (38%), 1 (58%), 2 (1%), unknown (3%). The stage distribution was: I (41%), stage II (32%) stage IIIA (25%), stage IIIB (1%). To date, 45/64 pts (70%) have completed 4 cycles within 12 weeks, and total of 50 (78%) of pts completed 4 cycles within 14 weeks. 11 pts have had D dose reduced, and 2 pts have had C dose reduced. 35 pts (55%) completed the 4 cycles at full dose within 12 weeks, and 38 patients (59%) within 14 weeks. Reasons for discontinuing treatment: withdrew from treatment (n=3), withdrew consent prior to initiating therapy (n=2), disease progression (n=2, brain metastases), adverse events (n=5), complication of other medical conditions (n=1), unknown reasons (n=1). Therapy was well tolerated and no treatment-related deaths were observed. Conclusions: Preliminary results indicate that adjuvant therapy with CD results in a similar rate of chemotherapy compliance to that of cisplatin-based chemotherapy. No significant financial relationships to disclose.

Compliance of adjuvant chemotherapy in non-small cell lung cancer (NSCLC); No longer an issue

7154 Background: Poor compliance has been a common feature in clinical trials of adjuvant chemotherapy for NSCLC with only 48%-69% of patients completing all planned cycles. This may have been due to lack of perceived benefit by patients and physicians and toxicity of the regimens employed. We retrospectively evaluated compliance and toxicity of platinum-based chemotherapy in the two years following the recent reports of successful adjuvant chemotherapy trials for NSCLC. Methods: Following institutional ethics approval, patients who received adjuvant chemotherapy after complete resection of NSCLC between May 2003 and May 2005 were analyzed retrospectively. Patients were identified using an institutional cancer registry. Patient demographics, ECOG status, stage, pathologic subtype and type of surgery were recorded. The number of chemotherapy cycles, delays, dose reductions and change of chemotherapy were all reported. Results: A total of 50 patients were identified. The median age was 62. 38% were stage I, 18% stage II, 30% stage III and 14% had multiple primary tumors of variable stages. 20% were ECOG PS2 and the rest ECOG 0–1. Only 12% had undergone pnemonectomy. 41 patients (82%) started cisplatin /vinorelbine (3 switched to carboplatin because of nephrotoxicity, and one switched to carboplatin/paclitaxel because of fatigue and vomiting). 3 patients received other cisplatin-based combinations. 6 received carboplatin-based treatment (one because of advanced age, one because of cardiac dysfunction and 4 because of preexisting neuropathy). 80% completed all treatment. 40% required dose reduction. 58% required delays in treatment. 6 events of febrile neutropenia were reported in 5 patients. 7 patients required admission. There were no toxic deaths. Multivariate analysis showed no effect of age, gender, extent of surgery or ECOG status on compliance, need for treatment modification or toxicity. Conclusions: Compared to historical trials, adjuvant platinum-based chemotherapy for resected NSCLC is well tolerated and is now accepted by patients and physicians with a high degree of compliance. No significant financial relationships to disclose.