Neck Dissections Based on Sentinel Lymph Node Navigation Versus Elective Neck Dissections in Early Oral Cancers: A Randomized, Multicenter, and Noninferiority Trial

2021 ◽  
pp. JCO.20.03637
Author(s):  
Yasuhisa Hasegawa ◽  
Kiyoaki Tsukahara ◽  
Seiichi Yoshimoto ◽  
Kouki Miura ◽  
Junkichi Yokoyama ◽  
...  
Keyword(s):  
Overall Survival ◽  
Lymph Node ◽  
Survival Rate ◽  
Sentinel Lymph Node ◽  
Lower Limit ◽  
Disease Free Survival ◽  
Sentinel Lymph Nodes ◽  
Free Survival ◽  
Node Negative ◽  
Disease Free

PURPOSE This study aimed to compare patients with early oral cavity squamous cell carcinoma (OCSCC) (tumor category [T] 1-2, node-negative, and no distant metastasis) treated with traditional elective neck dissection (ND) with those managed by sentinel lymph node biopsy (SLNB) using survival and neck function and complications as end points. METHODS Sixteen institutions in Japan participated in the study (trial registration number: UMIN000006510). Patients of age ≥ 18 years with histologically confirmed, previously untreated OCSCC (Union for International Cancer Control TNM Classification of Malignant Tumors 7th edition T1-2, node-negative no distant metastasis), with ≥ 4 mm (T1) depth of invasion, were randomly assigned to undergo standard selective ND (ND group; n = 137) or SLNB-navigated ND (SLNB group; n = 134). The primary end point was the 3-year overall survival rate, with a 12% noninferiority margin; secondary end points included postoperative neck functionality and complications and 3-year disease-free survival. Sentinel lymph nodes underwent intraoperative multislice frozen section analyses for the diagnosis. Patients with positive sentinel lymph nodes underwent either one-stage or second-look ND. RESULTS Pathologic metastasis-positive nodes were observed in 24.8% (34 of 137) and 33.6% (46 of 134) of patients in the ND and SLNB groups, respectively ( P = .190). The 3-year overall survival in the SLNB group (87.9%; lower limit of one-sided 95% CI, 82.4) was noninferior to that in the ND group (86.6%; lower limit 95% CI, 80.9; P for noninferiority < .001). The 3-year disease-free survival rate was 78.7% (lower limit 95% CI, 72.1) and 81.3% (75.0) in the SLNB and ND groups, respectively ( P for noninferiority < .001). The scores of neck functionality in the SLNB group were significantly better than those in the ND group. CONCLUSION SLNB-navigated ND may replace elective ND without a survival disadvantage and reduce postoperative neck disability in patients with early-stage OCSCC.

scholarly journals Perineural Invasion Is an Independent Predictor of Outcome in Colorectal Cancer

2009 ◽  
Vol 27 (31) ◽  
pp. 5131-5137 ◽  
Author(s):  
Catherine Liebig ◽  
Gustavo Ayala ◽  
Jonathan Wilks ◽  
Gordana Verstovsek ◽  
Hao Liu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Multivariate Analysis ◽  
Survival Rate ◽  
Perineural Invasion ◽  
Disease Free Survival ◽  
Free Survival ◽  
Node Negative ◽  
Disease Free Survival Rate ◽  
Disease Free

Purpose Perineural invasion (PNI) is associated with decreased survival in several malignancies, but its significance in colorectal cancer (CRC) remains to be clearly defined. We evaluated PNI as a potential prognostic indicator in CRC, focusing on its significance in node-negative patients. Patients and Methods We identified 269 consecutive patients who had CRC resected at our institution. Tumors were rereviewed for PNI by a pathologist blinded to the patients' outcomes. Overall and disease-free survivals were determined using the Kaplan-Meier method, with differences determined by multivariate analysis using the Cox multiple hazards model. Results were compared using the log-rank test. Results PNI was identified in less than 0.5% of the initial pathology reports. On rereview, 22% of tumors in our series were found to be PNI positive. The 5-year disease-free survival rate was four-fold greater for patients with PNI-negative tumors versus those with PNI-positive tumors (65% v 16%, respectively; P < .0001). The 5-year overall survival rate was 72% for PNI-negative tumors versus 25% for PNI-positive tumors. On multivariate analysis, PNI was an independent prognostic factor for both cancer-specific overall and disease-free survival. In a subset analysis comparing patients with node-negative disease with patients with stage III disease, the 5-year disease-free survival rate was 56% for stage III patients versus 29% for patients with node-negative, PNI-positive tumors (P = .0002). Similar results were seen for overall survival. Conclusion PNI is grossly underreported in CRC and could serve as an independent prognostic factor of outcomes in these patients. PNI should be considered when stratifying CRC patients for adjuvant treatment.

scholarly journals Serum cyfra21-1 associated with biological aggressiveness and poor prognosis in male patients with urothelial carcinoma of bladder.

2020 ◽  
Author(s):  
Haitao Liang ◽  
Yunlin Ye ◽  
Zhu Lin ◽  
Zikun Ma ◽  
Lei Tan ◽  
...  
Keyword(s):  
Overall Survival ◽  
Lymph Node ◽  
Lymphovascular Invasion ◽  
Disease Free Survival ◽  
Lymph Node Involvement ◽  
Free Survival ◽  
Node Involvement ◽  
Male Patients ◽  
Disease Free ◽  
Urothelial Carcinoma Of Bladder

Abstract Background : To assess the prognostic value of preoperative serum cyfra21-1 in male patients with urothelial carcinoma of bladder treated with radical cystectomy.Methods: Patients underwent radical cystectomy from 2009-2018 at our center were retrospectively analyzed and 267 male patients met our criterions. The median follow-up was 34 months. The serum level of cyfra21-1 was measured using enzyme linked immunosorbent assay. Patients were divided into two groups (cyfra21-1≤3.30ng/ml and cyfra21-1>3.30 ng/ml). Clinical significance of cyfra21-1 level was assessed.Results: Of the 267 patients, 110 (41.2%) had normal cyfra21-1, while 157 (58.8%) had elevated serum cyfra21-1. The prevalence of lymph node involvement, locally advanced stage (≥ pT3), tumor stages, tumor size and papillary were significantly higher in patients with elevated cyfra21-1 than in those with normal cyfra21-1. Patients with high cyfra21-1 showed worse Disease free survival and Overall survival than those with low cyfra21-1 ( P = 0.001 and 0.007, respectively). In multivariate analysis, High cyfra21-1, lymph node involvement, lymphovascular invasion and papillary were independent predictors of worse Disease free survival ( P = 0.036, <0.001, 0.002, 0.014 respectively). High cyfra21-1, lymph node involvement and lymphovascular invasion were also confirmed as independent predictors of worse Overall survival ( P = 0.038, 0.010, 0.005, respectively.)Conclusions: Elevated cyfra21-1 was associated with greater biological aggressiveness and worse prognosis than normal cyfra21-1.

Efficacy and tolerability of adjuvant therapy in ≥70-year-old patients with T3N0M0 colorectal cancer: An observational study

2019 ◽  
Vol 26 (3) ◽  
pp. 619-631
Author(s):  
Abdullah Sakin ◽  
Nurgul Yasar ◽  
Suleyman Sahin ◽  
Serdar Arici ◽  
Saban Secmeler ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Risk Group ◽  
Disease Free Survival ◽  
Old Patients ◽  
Free Survival ◽  
Disease Free

Background This study aimed to retrospectively investigate the efficacy and tolerability of adjuvant chemotherapy in ≥70-year-old patients with stage IIA (T3N0M0) colorectal cancer. Methods Lymphovascular invasion, perineural invasion, margin positivity, dissected lymph node count of <12, and presence of perforation/obstruction were accepted as risk factors. Those patients with at least one risk factor were regarded as having high risk. Results The study included 168 patients, among which 95 (56.5%) were male and 73 (43.5%) were female. The median age of patients was 73 years (range: 70–94). One hundred one (60.1%) patients were identified to have high risk. Eighty-one (87%) patients received 5-flourouracil+leucovorin and 12 (13%) patients received capecitabine regimens as adjuvant chemotherapy. The patients receiving capecitabine regimen had significantly higher rates of dose reduction at initiation and during the treatment. Among low-risk group, there was no statistically significant difference between patients with and without adjuvant chemotherapy in terms of disease-free survival or overall survival (p = 0.528 and p = 0.217, respectively). In high-risk group, patients receiving adjuvant chemotherapy significantly differed from those not receiving adjuvant chemotherapy in terms of median disease-free survival and overall survival (p = 0.009 and p < 0.001, respectively). While the grade, lymph node status, and adjuvant chemotherapy were identified as the most significant independent factors for disease-free survival, the most significant factors for overall survival were the age, Eastern Cooperative Oncology Group performance status, adjuvant chemotherapy, and recurrence. Conclusion The findings of our study showed improved disease-free survival and overall survival in high-risk ≥70-year-old patients who received adjuvant chemotherapy due to T3N0M0 colorectal cancer. We believe that 5-flourouracil+leucovorin or capecitabine regimens should be recommended for these older high-risk patients who could receive adjuvant chemotherapy regardless of age.

Randomized Clinical Trial of Adjuvant Mitomycin Plus Tegafur in Patients With Resected Stage III Gastric Cancer

1999 ◽  
Vol 17 (12) ◽  
pp. 3810-3815 ◽  
Author(s):  
Lluís Cirera ◽  
Anna Balil ◽  
Eduard Batiste-Alentorn ◽  
Ignasi Tusquets ◽  
Teresa Cardona ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Free Survival ◽  
Resected Stage ◽  
Disease Free

PURPOSE: The efficacy of adjuvant chemotherapy in gastric cancer is controversial. We conducted a phase III, randomized, multicentric clinical trial with the goal of assessing the efficacy of the combination of mitomycin plus tegafur in prolonging the disease-free survival and overall survival of patients with resected stage III gastric cancer. PATIENTS AND METHODS: Patients with resected stage III gastric adenocarcinoma were randomly assigned, using sealed envelopes, to receive either chemotherapy or no further treatment. Chemotherapy was started within 28 days after surgery according to the following schedule: mitomycin 20 mg/m2 intravenously (bolus) at day 1 of chemotherapy; 30 days later, oral tegafur at 400 mg bid daily for 3 months. Disease-free survival and overall survival were estimated using the Kaplan-Meier analysis and the Cox proportional hazards model. RESULTS: Between January 1988 and September 1994, 148 patients from 10 hospitals in Catalonia, Spain, were included in the study. The median follow-up period was 37 months. The tolerability of the treatment was excellent. The overall survival and disease-free survival were higher in the group of patients treated with chemotherapy (P = .04 for survival and P = .01 for disease-free survival in the log-rank test). The overall 5-year survival rate and the 5-year disease-free survival rate were, respectively, 56% and 51% in the treatment group and 36% and 31% in the control group. CONCLUSION: Our positive results are consistent with the results of recent studies; which conclude that there is a potential benefit from adjuvant chemotherapy in resected gastric cancer.

Pelvic Irradiation With Concurrent Chemotherapy Versus Pelvic and Para-Aortic Irradiation for High-Risk Cervical Cancer: An Update of Radiation Therapy Oncology Group Trial (RTOG) 90-01

2004 ◽  
Vol 22 (5) ◽  
pp. 872-880 ◽  
Author(s):  
Patricia J. Eifel ◽  
Kathryn Winter ◽  
Mitchell Morris ◽  
Charles Levenback ◽  
Perry W. Grigsby ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Disease Stage ◽  
Tumor Diameter ◽  
Free Survival ◽  
Stage Ib ◽  
Disease Free

Purpose To report mature results of a randomized trial that compared extended-field radiotherapy (EFRT) versus pelvic radiotherapy with concomitant fluorouracil and cisplatin (CTRT) in women with locoregionally advanced carcinomas of the uterine cervix. Patients and Methods Four hundred three women with cervical cancer were randomly assigned to receive either EFRT or CTRT. Patients were eligible if they had stage IIB to IVA disease, stage IB to IIA disease with a tumor diameter ≥ 5 cm, or positive pelvic lymph nodes. Patients were stratified by stage and by method of lymph node evaluation. Results The median follow-up time for 228 surviving patients was 6.6 years. The overall survival rate for patients treated with CTRT was significantly greater than that for patients treated with EFRT (67% v 41% at 8 years; P < .0001). There was an overall reduction in the risk of disease recurrence of 51% (95% CI, 36% to 66%) for patients who received CTRT. Patients with stage IB to IIB disease who received CTRT had better overall and disease-free survival than those treated with EFRT (P < .0001); 116 patients with stage III to IVA disease had better disease-free survival (P = .05) and a trend toward better overall survival (P = .07) if they were randomly assigned to CTRT. The rate of serious late complications of treatment was similar for the two treatment arms. Conclusion Mature analysis confirms that the addition of fluorouracil and cisplatin to radiotherapy significantly improved the survival rate of women with locally advanced cervical cancer without increasing the rate of late treatment-related side effects.

scholarly journals Influence of Sentinel Lymph Node Biopsy on Disease-Free Survival for Melanoma Patients

2014 ◽  
Vol 25 ◽  
pp. iv388
Author(s):  
M. Kukushkina ◽  
S. Korovin ◽  
O. Solodiannikova ◽  
G. Sukach ◽  
A. Palivets ◽  
...  
Keyword(s):  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Sentinel Lymph Node Biopsy ◽  
Disease Free Survival ◽  
Lymph Node Biopsy ◽  
Free Survival ◽  
Node Biopsy ◽  
Melanoma Patients ◽  
Disease Free
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