scholarly journals Treatment of Diffuse Large Cell Lymphoma (DLBCL) Patients Older Than 75 Years: Higher Mortality and Risk of Complications without Increased Risk of Relapse after Treatment

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1863-1863
Author(s):  
Akiva Diamond ◽  
Sabarish Ram Ayyappan ◽  
Raisa Pinto ◽  
Ehsan Malek ◽  
Ben K. Tomlinson ◽  
...  

Abstract Introduction: The prognostic relevance of age at diagnosis has long been recognized in DLBCL. Its role in the biology of disease has not been clarified, and it has been postulated that the worse prognosis of older DLBCL patients is a result of more aggressive disease combined with poor tolerance to aggressive therapy. The introduction of rituximab has improved the outcomes of DLBCL in all ages, whereas reduced dose and anthracycline-free regimens have improved access of elderly patients to more effective DLBCL therapy. Methods: We accessed the Hematologic Malignancies database of University Hospitals Seidman Cancer Center for DLBCL patients diagnosed between 2002 and 2014. Information collected included demographic as well as baseline laboratory and disease characteristics. Relapse and overall survival times were calculated from end of therapy and time of diagnosis, respectively, using the Kaplan Meier method, comparisons were done using the log-rank test. Cumulative incidence of major cardiovascular events (including myocardial infarction, coronary artery disease without infarction, congestive heart failure and arrhythmias) were calculated using death as competing risk; comparisons between groups were done using the Gray test. Results: A total of 400 DLBCL patients were identified, 95 were older than 75 years. Table 1 shows the baseline demographic and disease characteristics. Older patients had a higher incidence of comorbidities and higher rates of decreased performance status. There were no other differences in baseline disease characteristics. A smaller proportion of older patients proceeded to receive antineoplastic therapy (81% vs. 91%, p = 0.002). Therapy for older subjects was less intense (full dose R-CHOP 54.5% vs. 81.1%, p<0.001) with more planned and unplanned dose reductions (48% vs. 11%, p<0.001). Despite less intense therapy, response rates were not statistically different between the two age groups (84% vs. 87%, p = 0.687). After a median of 28 months follow up, estimated 3-year overall survival was 51% (95% CI 40-61.8%) for patients >75 years vs. 76% for younger patients (95% CI 70.6-80.9%)(p<0.001). In patients who received therapy (n=77 older than 75 years; n=281 for < 75 years), there was no difference in relapse-free survival from the start of treatment (3-year RFS: 77% (95% CI 66.5-88.5%) for patients > 75 years and 65% (95% CI 59.1-71.6%) for younger patients, p=0.155). The cumulative incidence (CI) of cardiovascular events, with death due to any other cause as a competing risk, was higher in subjects >75 years: 1-year CI was 15.3% vs. 7.6% in younger patients (p = 0.04). Conclusions: DLBCL patients older than 75 years have a higher mortality risk following DLBCL diagnosis than younger patients, despite having similar response rates and relapse free survival. While chemotherapy dose reduction does not appear to affect disease control, high rates of cardiovascular events suggest future studies should focus on the minimization of short and long term toxicities of therapy. Disclosures No relevant conflicts of interest to declare.

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 575-575 ◽  
Author(s):  
Madison Keenan ◽  
Kirsten Marie Boughan ◽  
Brenda Cooper ◽  
Molly M Gallogly ◽  
Stanton L. Gerson ◽  
...  

Abstract Introduction: Very advanced age (≥80 years) DLBCL patients have worse prognosis. These unfavorable outcomes are largely considered to be a result of the combined effects of increased comorbidities, frailty, diminished tolerance and access to effective chemoimmunotherapy. It is not clear yet whether DLBCL patients of very advanced age have disease that is intrinsically more aggressive. Methods: We accessed the Stem Cell Transplant and Hematologic Malignancies database of University Hospitals Seidman Cancer Center for DLBCL patients diagnosed between 2000 and 2016. Information collected included demographic characteristics, baseline laboratory and disease information, as well as treatment details. Progression free survival and overall survival were calculated from time of diagnosis using Kaplan Meier methodology, comparisons were done with log rank. Cumulative incidence of relapse with death as competing risk was calculated for patients who underwent treatment, comparisons between age groups were done with the Gray test. Results: A total of 542 DLBCL patients were identified, 85 (16%) were older than 80 years. Table 1 shows the baseline demographic and disease characteristics. Older patients had a higher incidence of comorbidities, specifically cardiovascular comorbidities, prior renal insufficiency, and hyperlipidemia. Expectedly, very elderly patients had higher R-IPI, with a trend towards worse performance status that did not reach statistical difference. The proportion of patients diagnosed with non - germinal center DLBCL was not different than younger DLBCL patients, and there was no statistical difference in the incidence of double expressor or double hit lymphomas, possibly secondary to the small number of patients tested. A smaller proportion of patients ≥ 80 years received antineoplastic therapy (89% vs. 98%, p = 0.001), and use of less intense therapy was more common (table 2). Sixty one percent of patients, however, were still treated with R-CHOP (38.8%) or R-miniCHOP (22.2%). The overall response rate (ORR) for any therapy was 68.2%, lower than the ORR for younger patients (85.9%, p = 0.007). When only patients treated with RCHOP/R-miniCHOP were included, the difference in ORR was smaller, though still statistically significant (77.5% vs. 89.8%, p = 0.021). Median number of cycles was similar (5 vs. 6 cycles, respectively). Patients of all ages treated with single agent rituximab presented an ORR of 43%. After a median of 40 months follow up, estimated 4-year overall survival was 42% (95% CI 31-54%) for patients ≥ 80 years, 67% for patients aged between 60 and 79 years (95% CI 61-74%) and 78% for patients < 60 years (95% CI 73-84%) (Figure 1). Four - year survival for patients ≥80 years treated with R-CHOP or R-miniCHOP chemoimmunotherapy was 50% (95% CI 36-65%) vs. 75% for younger patients (95% CI 70-79%) (p<0.001), with 4-year PFS of 48% vs. 63% (95% CI 58-68%) (p = 0.04). Cumulative incidence of relapse (with death in remission as competing risk) for chemoimmunotherapy - treated patients at 1 and 4 years was 10% (95% CI 4-22%) and 20% (95% CI 11-37%), respectively for patients older than 80 years and 20% (95% CI 11-36%) and 29% (95% CI 25-35%), respectively for younger patients (p = 0.12) (Figure 2). There was no observed difference in the rates of disease - related mortality (53% vs. 61%, p = 0.5). Conclusions: Very elderly (≥80 years of age) DLBCL patients have significantly worse overall survival, progression free survival, and treatment response rates than younger patients. However, when chemoimmunotherapy is feasible, disease relapse rates are comparable to those of younger patients, and increased mortality does not appear to be a result of increased disease relapse. Additional research is needed to establish more widely applicable, better tolerated effective treatment regimens for this patient population. Disclosures Lazarus: Pluristem Ltd.: Consultancy. Malek:Takeda: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; Sanofi: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau. Tomlinson:Foundation Medicine: Consultancy. Caimi:Genentech: Other: Advisory Board PArticipation, Research Funding; Kite Pharma: Other: Advisory Board Participation; Celgene: Speakers Bureau; Kite Pharma: Other: Advisory Board Participation.


2021 ◽  
Author(s):  
Yanan Zhang ◽  
Zeyang Chen ◽  
Guanqi Gao

Abstract Background. Lung cancer is one of the most common malignancy worldwide and causes estimated 1.6 million deaths each year. Cancer immunosurveillance has been found to play an important role in lung cancer and may be related with its prognosis. KLRK1, encoding NKG2D, is a homodimeric lectin-like receptor. However, there has not been one research of KLRK1 as a biomarker in lung cancer.Methods. Data including patients` clinical characteristics and RNAseq information of KLRK1 from TCGA were downloaded. A total of 1019 patients with lung cancer were included in this study, among which 407 patients were female and 611 patients were male. Evaluations of mRNA expression, diagnostic value by ROC (Receiver operating characteristic) curves and prognostic value by survival curve, Cox model and subgroup analysis were performed. The CCK-8 assay investigated the proliferation rate and the wound healing assay assessed the migratory ability in vitro.Results. The expression of KLRK1 in tumor was lower than that in normal tissue. KLRK1 expression was associated with gender, histologic grade, stage, T classification and vital status. Patients with high KLRK1 expression presented an improved overall survival (P=0.0036) and relapse free survival (P=0.0031). KLRK1 was found to have significant prognostic value in lung adenocarcinoma (P=0.015), stage I/II (P=0.03), older patients (P=0.0052), and male (P=0.0047) by subgroup overall survival analysis, and in lung adenocarcinoma (P=0.0094), stage I/II (P=0.0076), older patients (P=0.0072) , and male (P=0.0033) by subgroup relapse free survival analysis. Lung adenocarcinoma cancer patients with high KLRK1 expression presented an improved overall survival (P=0.015) and relapse free survival (P=0.0094). In vitro studies indicated that KLRK1 inhibited tumor cell proliferation and migration.Conclusions. KLRK1 was an independent prognostic factor and high KLRK1 expression indicated a better overall and relapse free survival. KLRK1 may be a prognostic biomarker for lung adenocarcinoma cancer.


2021 ◽  
Vol 5 (9) ◽  
pp. 2294-2304
Author(s):  
Michael Heuser ◽  
Bennet Heida ◽  
Konstantin Büttner ◽  
Clara Philine Wienecke ◽  
Katrin Teich ◽  
...  

Abstract Next-generation sequencing (NGS)-based measurable residual disease (MRD) monitoring in patients with acute myeloid leukemia (AML) is widely applicable and prognostic prior to allogeneic hematopoietic cell transplantation (alloHCT). We evaluated the prognostic role of clonal hematopoiesis–associated DNMT3A, TET2, and ASXL1 (DTA) and non-DTA mutations for MRD monitoring post-alloHCT to refine MRD marker selection. Of 154 patients with AML, 138 (90%) had at least one mutation at diagnosis, which were retrospectively monitored by amplicon-based error-corrected NGS on day 90 and/or day 180 post-alloHCT. MRD was detected in 34 patients on day 90 and/or day 180 (25%). The rate of MRD positivity was similar when DTA and non-DTA mutations were considered separately (17.6% vs 19.8%). DTA mutations had no prognostic impact on cumulative incidence of relapse, relapse-free survival, or overall survival in our study and were removed from further analysis. In the remaining 131 patients with at least 1 non-DTA mutation, clinical and transplantation-associated characteristics were similarly distributed between MRD-positive and MRD-negative patients. In multivariate analysis, MRD positivity was an independent adverse predictor of cumulative incidence of relapse, relapse-free survival, and overall survival but not of nonrelapse mortality. The prognostic effect was independent of different cutoffs (above limit of detection, 0.1% and 1% variant allele frequency). MRD log-reduction between diagnosis and post-alloHCT assessment had no prognostic value. MRD status post-alloHCT had the strongest impact in patients who were MRD positive prior to alloHCT. In conclusion, non-DTA mutations are prognostic NGS-MRD markers post-alloHCT, whereas the prognostic role of DTA mutations in the posttransplant setting remains open.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3501-3501
Author(s):  
Dipenkumar Modi ◽  
Abhinav Deol ◽  
Seongho Kim ◽  
Kendra Mellert ◽  
Marie Ventimiglia ◽  
...  

Abstract Introduction: Patients with AML and MDS who are age 60 or above represent a discrete group of patients with a different disease biology compared to younger patients. These patients are often not offered allogeneic hematopoietic stem cell transplant (HSCT) as a curative intent because of concern of increased nonrelapse mortality (NRM) and poor overall survival (OS). Hence, the information on transplant outcomes among this population is very limited. Recently with the use of better supportive care measures and reduced intensity preparative regimens, patients greater than 60 are often recommended to proceed to transplant. This study evaluates our single center experience of allogeneic transplantation in patients with MDS and AML aged 60 and older. Patients and Methods: We retrospectively evaluated 60 years or older consecutive patients with AML and MDS who underwent allogeneic HSCT between January 2005 and December 2014. The primary objectives of our study were to determine NRM, relapse, relapse free survival (RFS) and OS at 1 year following transplant. The secondary objectives were to estimate cumulative incidence of acute (aGVHD) and chronic GVHD (cGVHD) at 1 year, length of stay and readmission rate in the first 100 days following transplant. Results: Between January 2005 and December 2014, 159 patients underwent allogeneic HSCT with the median age of 64 (range, 60-75) years and median follow-up duration for OS of 3.34 (95% CI, 2.51-3.87) years. Increasing number of patients were transplanted in recent years, i.e., 67% patients between 2010-2014 compared to 33% between 2005-2009. One hundred three patients (65%) had AML and 56 patients (35%) had MDS. Forty-nine patients (31%) received full intensity regimen and 110 patients (69%) received reduced intensity regimen. Fifty-two patients (33%) underwent allogeneic related transplant and 107 patients (67%) had allogeneic unrelated transplant. Thymoglobulin based GVHD prophylaxis was given in 77 patients (48%) whereas non-thymoglobulin based GVHD prophylaxis was given in 82 patients (52%). The median day to neutrophil and platelet engraftment was 11 (range, 7-22) days and 16 (range, 0-675) days, respectively. Graft failure occurred in 3 patients. At 1-year follow-up, the cumulative incidence of grade II-IV aGVHD was 39.7% (95% CI, 32.0-47.2%), grade III-IV aGVHD was 20.8% (95% CI, 14.9-27.5%) and cGVHD was 54.1% (95% CI, 46.0-61.5%). The cumulative incidence of chronic extensive GVHD was 39.8% (95% CI, 32.1-47.4%). Blood stream infection, cytomegalovirus reactivation, Epstein-Barr virus reactivation, C. difficile diarrhea occurred in 44%, 35%, 22% and 26% of patients, respectively. At 1-year follow-up, NRM was 25.3% (95% CI, 18.8-32.3%), RFS was 53.3% (95% CI, 46.1-61.7%), relapse rate was 21.4% (95% CI, 15.4-28.1%) and OS was 56.4% (95% CI, 49.2-54.7%). The median day of hospitalization following transplant was 26 (range, 19-112) days and almost half (52%) of patients were readmitted in the first 100 days following transplant. Leukemia recurrence was the most common cause of death. Multivariable analysis demonstrated high disease risk index to be the independent predictor of poor RFS, OS and higher relapse rate (p<0.03), whereas non-thymoglobulin based GVHD prophylaxis, higher comorbidity index (≥3) and MDS were found to be associated with higher NRM (p<0.03). Most importantly, age did not shown to have any effect on relapse rate, OS, RFS, or NRM. Conclusion: Our results indicate that allogeneic HSCT is well tolerated and had acceptable NRM, and OS among this group. Hence, older age alone should not be considered a contraindication to HSCT. Figure 1 Overall survival (OS) and relapse-free survival (RFS) estimates. The median OS is 1.60 years (95% CI, 0.94 to 5.00 years) and the median RFS is 1.15 years (95% CI, 0.63 to 3.07 years). The median follow-up time of OS and RFS are 3.34 years (95% CI, 2.51 to 3.87 years) and 3.25 years (95% CI, 2.51 to 3.87 years), respectively. Figure 1. Overall survival (OS) and relapse-free survival (RFS) estimates. The median OS is 1.60 years (95% CI, 0.94 to 5.00 years) and the median RFS is 1.15 years (95% CI, 0.63 to 3.07 years). The median follow-up time of OS and RFS are 3.34 years (95% CI, 2.51 to 3.87 years) and 3.25 years (95% CI, 2.51 to 3.87 years), respectively. Figure 2 Cumulative incidences of aGVHD, cGVHD, relapse and non-relapse mortality after transplantation. Figure 2. Cumulative incidences of aGVHD, cGVHD, relapse and non-relapse mortality after transplantation. Disclosures Deol: Jazz Pharmaceuticals: Consultancy.


2020 ◽  
Vol 4 (24) ◽  
pp. 6117-6126
Author(s):  
Nicholas J. Short ◽  
Hind Rafei ◽  
Naval Daver ◽  
Hyunsoo Hwang ◽  
Jing Ning ◽  
...  

Abstract In relapsed/refractory acute myeloid leukemia (AML), the prognostic impact of complete remission (CR) and measurable residual disease (MRD) negativity is not well established. We retrospectively analyzed 141 patients with relapsed/refractory AML who received first salvage therapy and had MRD assessed by multiparameter flow cytometry at the time of response. Patients who achieved CR with full hematologic recovery as best response vs those with incomplete hematology recovery had lower cumulative incidence of relapse (P = .01) and better relapse-free survival (P = .004) but not overall survival (P = .15); a similar trend was observed in patients who achieved MRD negativity vs those who were MRD positive (P = .01, P = .05, and P = .21, respectively). By multivariate analysis, CR and MRD negativity were each independently associated with lower cumulative incidence of relapse (P = .001 and P = .003, respectively) and better relapse-free survival (P &lt; .001 and P = .02) but not overall survival. Patients who achieved CR with MRD negativity had the lowest rates of relapse and best survival (2-year overall survival rate, 37%), which was driven largely by lower rates of early relapse and an increased ability in this group to undergo hematopoietic stem cell transplantation (HSCT); however, post-HSCT outcomes were similar regardless of response to salvage chemotherapy. Overall, in patients with relapsed/refractory AML, CR with MRD negativity was associated with the best outcomes, supporting it as the optimal response in this setting.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3409-3409
Author(s):  
Carla Borgono ◽  
Young Trieu ◽  
Wei Xu ◽  
Donna E. Reece ◽  
Suzanne Trudel ◽  
...  

Abstract Abstract 3409 Poster Board III-297 Introduction: MM is a disease of the elderly with a median age at diagnosis of 65 years. For younger patients (<65 years), melphalan-based ASCT is standard therapy. However, limited data are available on the efficacy of ASCT in elderly patients (pts) over age 70, with concerns of excess toxicity and transplant-related mortality (TRM). Methods: From October 2000-August 2006, 548 MM pts were transplanted at our institution, 33 of whom (6%) were ≥70 years in age. Baseline demographics, disease characteristics, transplant and survival outcomes, including toxicities were collected retrospectively on all 548 patients and differences between the older patients (≥70 years) vs the younger pts (<70 years) were analyzed. Patients receiving a second salvage or tandem transplant were excluded. As per institutional transplant standard, all patients received 3-6 cycles of high-dose dexamethasone (DEX)-based induction therapy, underwent peripheral blood stem cell mobilization with cyclophosphamide 2.5g/m2 and GCSF 10mg/kg/day, and received melphalan 200mg/m2 for conditioning (no routine dose reductions for age). Ciprofloxacin prophylaxis and GCSF use (from day 7) were used routinely during the transplant process. Results: A total of 548 MM pts were studied: 33 pts ≥70 yrs of age (median 71 yrs; range 70-74); 515 pts <70 years of age (median 59 yrs; range 29-69). Patient and disease characteristics: MM subtypes for all pts included: IgG (59%), IgA (19%), biphenotypic (2%), IgD and IgM (<1%), light chain only (5%), other (10%) (no differences between the 2 groups). For the ≥70 yrs pts at baseline: median Hb was 98g/L (range 73-141), 22% of pts were hypercalcemic at diagnosis (median 2.38 mmol/L; range 2.09-4.24), 48% had significant renal dysfunction with serum creatinine >177 umol/L at diagnosis (median creatinine 94 umol/L; range 60-450), and 79% had elevated serum beta-2 microglobulin at diagnosis (median 269 nmol/L, range 5.8-505). No differences in baseline lab values were noted between the elderly and younger groups. Comorbid disorders in the elderly pts were common: 36% cardiac conditions (hypertension, coronary artery disease, heart failure, arrthythmias), 18% prior or pre-existing malignancy (solid tumours, lymphoma, leukemia), 12% diabetes, 12% gastrointestinal (ulcers, diverticular disease, colitis), 21% prior major infection (sepsis, pneumonia, TB), 6% renal disease (chronic renal failure, cystic disease), 6% CNS (stroke, seizures). Both renal disease and prior major infections were more common in the ≥70 group (renal 6 vs 1%, p=0.04 and infections 21 vs 5%, p=0.0003. Transplant outcomes: Although a standard stem cell mobilizing procedure was utilized for all pts, fewer stem cells (CD34+ cells) were collected in the ≥70 age group in comparison to the younger pts (median 12.3 vs. 9.1 × 106/kg; p=0.004). This did not, however, translate into significant differences in days to neutrophil or platelet engraftment, nor in days of hospitalization. For the ≥70 group, 76% achieved a PR (9% VGPR/CR) as assessed 3 months post-transplant, similar to the <70 group (p=0.08). Median progression-free survival from transplant was similar between groups (23.7 vs 21.8 mos, p=0.65) but median overall survival of the elderly pts was significantly shorter than that of younger patients (46.3 vs 80.4 mos, p = 0.03). Causes of death are unknown. Toxicities: Older patients exhibited cardiac toxicities (primarily arrhythmias) more frequently than younger patients during the transplant period (grade 1/2 - 3% vs 6%, grade 3/4 – 0 vs. 2%; p<0.0001). Treatment-related deaths, however, were uncommon in both groups [none in ≥70 pts vs 1.3% in <70 pts (p=0.27)]. Conclusions: Disclosures: Reece: Ortho Biotech: Honoraria, Research Funding.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Gang Xu ◽  
Hisaki Aiba ◽  
Norio Yamamoto ◽  
Katsuhiro Hayashi ◽  
Akihiko Takeuchi ◽  
...  

Abstract Background Synovial sarcoma is an aggressive but chemosensitive soft-tissue tumor. We retrospectively analyzed the efficacy of perioperative chemotherapy for synovial sarcoma with data from the nationwide database, Bone and Soft Tissue Tumor Registry in Japan. Methods This study included 316 patients diagnosed with synovial sarcoma between 2006 and 2012. Oncologic outcomes were analyzed using a Cox-hazard regression model. Moreover, the effects of perioperative chemotherapy on outcomes were evaluated using a matched-pair analysis. The oncologic outcomes of patients who did or did not receive chemotherapy were compared (cx + and cx-). Results Multivariate analysis revealed significant correlations of age (over 40, hazard ratio [HR] = 0.61, p = 0.043), margin status (marginal resection, HR = 0.18, p < 0.001 and intralesional resection, HR = 0.30, p = 0.013 versus wide resection) with overall survival; surgical margin type (marginal resection, HR = 0.14, p = 0.001 and intralesional resection, HR = 0.09, p = 0.035 versus wide resection) with local recurrence; and postoperative local recurrence (HR = 0.30, p = 0.027) and surgical margin (marginal resection, HR = 0.31, p = 0.023 versus wide resection) with distant relapse-free survival. Before propensity score matching, perioperative chemotherapy was mainly administered for young patients and patients with deeper tumor locations, larger tumors, more advanced-stage disease, and trunk location. The 3-year overall survival, local control, and distant relapse-free survival rates were 79.8%/89.3% (HR = 0.64, p = 0.114), 89.6%/93.0% (HR = 0.37, p = 0.171) and 71.4%/84.5% (HR = 0.60, p = 0.089) in the cx+/cx- groups, respectively. After propensity score matching, 152 patients were selected such that the patient demographics were nearly identical in both groups. The 3-year overall survival, local control, and distant relapse-free survival rates were 71.5%/86.0% (HR = 0.48, p = 0.055), 92.5%/93.3% (HR = 0.51, p = 0.436) and 68.4%/83.9% (HR = 0.47, p = 0.046) in the cx+/cx- groups, respectively. Conclusion This large-sample study indicated that the margin status and postoperative disease control were associated directly or indirectly with improved oncologic outcomes. However, the efficacy of perioperative chemotherapy for survival outcomes in synovial sarcoma patients was not proven in this Japanese database analysis.


2003 ◽  
Vol 21 (12) ◽  
pp. 2282-2287 ◽  
Author(s):  
Atsushi Nashimoto ◽  
Toshifusa Nakajima ◽  
Hiroshi Furukawa ◽  
Masatsugu Kitamura ◽  
Taira Kinoshita ◽  
...  

Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-negative gastric cancer patients (excluding patients who were T1N0), we conducted a multicenter phase III clinical trial in which 13 cancer centers in Japan participated. Patients and Methods: From January 1993 to December 1994, 252 patients were enrolled into the study and allocated randomly to adjuvant chemotherapy or surgery alone. The chemotherapy comprised intravenous mitomycin 1.33 mg/m2, fluorouracil (FU) 166.7 mg/m2, and cytarabine 13.3 mg/m2 twice weekly for the first 3 weeks after surgery, and oral FU 134 mg/m2 daily for the next 18 months for a total dose of 67 g/m2. The primary end point was relapse-free survival. Overall survival and the site of recurrence were secondary end points. Results: Ninety-eight percent of patients underwent gastrectomy with D2 or greater lymph node dissection. There were no treatment-related deaths and few serious adverse events. There was no significant difference in relapse-free and overall survival between the arms (5-year relapse-free survival 88.8% chemotherapy v 83.7% surgery alone; P = .14 and 5-year survival 91.2% chemotherapy v 86.1% surgery alone; P = .13, respectively). Nine patients (7.1%) in the chemotherapy arm and 17 patients (13.8%) in the surgery-alone arm had cancer recurrence. Conclusion: There was no statistically significant relapse-free or overall survival benefit with this adjuvant chemotherapy for patients with macroscopically serosa-negative gastric cancer after curative resection, and there was no statistical difference between the two arms relating to the types of cancer recurrence. We do not recommend adjuvant chemotherapy with this regimen for this population in clinical practice.


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