A randomized phase III study to evaluate the value of the omission of prophylactic neck dissection for stage I/II tongue cancer (RESPOND: JCOG1601)

LBA5510 Background: One option to increase the efficacy of TC in pts with first diagnosis of ovarian cancer is to add a not cross-resistant drug. Methods: We conducted a randomized, prospective, stratified, phase III study comparing therapy with TC to TC plus gemcitabine. From 7/02 to 4/04, pts with a histological verified first diagnosis of epithelial OC, FIGO IC-IV were randomized to either TC (paclitaxel [T] 175 mg/m2 3h iv d1 + carboplatin [C] AUC 5 iv d1) or TCG (TC + gemcitabine [G] 800 mg/m2 iv d1+8) for at least 6 cycles every 21 days starting within 6 weeks post-operatively. The randomization was balanced within three strata: 1) FIGO I-IIA, 2) FIGO IIB-IIIC with residual tumor ≤ 10mm, 3) FIGO IIB-IIIC with residual tumor > 10 mm or FIGO IV. Primary endpoint is overall survival. Results: We enrolled 1,742 pts and administered 5,268 cycles TC and 5,129 cycles TCG. All baseline characteristics of the patients in both arms were well balanced. Most pts received 6+ cycles (87.2% TC, 86.2% TCG). Previous interim analyses has shown that TCG was tolerable but induced more hematological toxicity and final analysis has shown that addition of gemcitabine did not improve overall survival in patients with FIGO stage IIB-IV disease. Approximately 11% of the patients (n = 175) had FIGO stage I-IIA disease (stratum I). Most patients received 6+ cycles (93.3% TC, 86.9% TCG). With a median follow-up of 53.8 (range 0 –75) months, and using the log rank test and Cox regression analysis, no relevant differences in progression free survival (first quartile about 57 months and median ≥ 75 months in both groups, HR = 0.90 [95% CI: 0.47–1.72], p = 0.7500) and a negative trend in overall survival (first quartile ≥ 75 months in both groups, HR = 2.19 [95% CI: 0.75–6.41], p = 0.1419) were seen. Conclusions: Addition of G to TC did not improve efficacy in patients with stage I-IIA ovarian cancer. This was also the case for stratum II-III patients (previously reported). The addition of G to TC in patients with first diagnosis of ovarian cancer cannot be recommended. [Table: see text]

Download Full-text

Elective Neck Dissection, but Not Adjuvant Radiation Therapy, Improves Survival in Stage I and II Oral Tongue Cancer with Depth of Invasion >4 mm

Cureus ◽

10.7759/cureus.6288 ◽

2019 ◽

Author(s):

Justin Mann ◽

Diana Julie ◽

Sean S Mahase ◽

Debra D'Angelo ◽

Louis Potters ◽

...

Keyword(s):

Radiation Therapy ◽

Neck Dissection ◽

Tongue Cancer ◽

Stage I ◽

Elective Neck Dissection ◽

Adjuvant Radiation ◽

Depth Of Invasion ◽

Oral Tongue ◽

Adjuvant Radiation Therapy ◽

Oral Tongue Cancer

Download Full-text

Evaluation of prophylactic neck dissection in Stage I and II oral squamous cell carcinoma

Japanese Journal of Oral & Maxillofacial Surgery ◽

10.5794/jjoms.55.622 ◽

2009 ◽

Vol 55 (12) ◽

pp. 622-628

Author(s):

Soichi HIRASHIMA ◽

Izumi YOSHIOKA ◽

Manabu HABU ◽

Norihiko FURUTA ◽

Shinya KOKURYO ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Oral Squamous Cell Carcinoma ◽

Cell Carcinoma ◽

Neck Dissection ◽

Squamous Cell ◽

Stage I ◽

Prophylactic Neck Dissection

Download Full-text

The ABC-study: A randomized phase III study comparing one course of adjuvant bleomycin, etoposide, and cisplatin (BEP) and one course of carboplatin AUC7 in clinical stage I seminomatous testicular cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.tps4593 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. TPS4593-TPS4593

Author(s):

Torgrim Tandstad ◽

Olof Stahl ◽

Olav Dahl ◽

Ingrid Glimelius ◽

Hege Sagstuen Haugnes ◽

...

Keyword(s):

Risk Factors ◽

Testicular Cancer ◽

Relapse Rate ◽

Adjuvant Treatment ◽

Clinical Stage ◽

Dropout Rate ◽

Rete Testis ◽

Stage I ◽

Phase Iii ◽

Phase Iii Study

TPS4593 Background: Clinical stage I seminomatous testicular cancer is by far the most frequent presentation of testicular cancer. Treatment options include surveillance or adjuvant treatment, internationally one course of adjuvant carboplatin (AUC7) is the preferred adjuvant treatment. Tumor size and stromal invasion in the rete testis can be used to identify patients with a higher risk of relapse. Recent data have showed only a modest effect of adjuvant carboplatin in preventing relapse, and more potent adjuvant therapies should be explored to this group of patients. Methods: The ABC-study is a investigator initiated randomized, open, phase III study comparing standard adjuvant chemotherapy in the form of one course carboplatin AUC7 to one course of BEP (Bleomycin, etoposide and cisplatin), in patients with one or two risk factors. Based on SWENOTECA data from one course of adjuvant carboplatin AUC7 we estimate the relapse rate in patients with one or two risk factors to be 9 %. We consider a reduction in relapse free survival of 7 % to be the minimum difference that will lead to routine use of one course of adjuvant BEP. To demonstrate an improvement in relapse rate from 9 to 2 % with an α = 0.05 and β = 0.80, 332 evaluable patients are required. We expect a dropout rate of maximum 5 %, and therefore intend to randomize a total of 348 patients. Enrollment in the study started in 2015, and as of February 1. 2017 a total of 66 patients have been enrolled. Accrual have been slower than expected, but the current accrual rate is about 6-7 patients a month. We invite institutions and collaboratory groups to participate in this study. NCT02341989. EUDRACT 2014-004075-23. Clinical trial information: NCT02341989.

Download Full-text

Randomized Phase III Study of Irinotecan Plus Cisplatin Versus Etoposide Plus Cisplatin for Completely Resected High-Grade Neuroendocrine Carcinoma of the Lung: JCOG1205/1206

Journal of Clinical Oncology ◽

10.1200/jco.20.01806 ◽

2020 ◽

Vol 38 (36) ◽

pp. 4292-4301

Author(s):

Hirotsugu Kenmotsu ◽

Seiji Niho ◽

Masahiro Tsuboi ◽

Masashi Wakabayashi ◽

Genichiro Ishii ◽

...

Keyword(s):

Neuroendocrine Carcinoma ◽

Stage I ◽

Phase Iii ◽

High Grade ◽

Open Label ◽

Intention To Treat ◽

Open Label Phase ◽

Phase Iii Study ◽

Grade 3 ◽

Resected Stage

PURPOSE To verify the superiority of irinotecan plus cisplatin over etoposide plus cisplatin as postoperative adjuvant chemotherapy for patients with pathologic stage I-IIIA, completely resected, high-grade neuroendocrine carcinoma (HGNEC) of the lung. METHODS This was a randomized, open-label, phase III study on patients with completely resected stage I-IIIA HGNEC of the lung. They were randomly assigned to receive either etoposide (100 mg/m2, days 1-3) plus cisplatin (80 mg/m2, day 1) or irinotecan (60 mg/m2, days 1, 8, 15) plus cisplatin (60 mg/m2, day 1) up to four cycles. The primary end point was relapse-free survival (RFS) in the intention-to-treat population. This trial was registered with the Japan Registry of Clinical Trials (jRCTs031180216). RESULTS Between April 2013 and October 2018, 221 patients were enrolled (etoposide plus cisplatin arm, 111 patients; irinotecan plus cisplatin arm, 110 patients). In the second interim analysis, early termination of the trial was recommended because of futility. At a median follow-up of 24.1 months, the 3-year RFS was 65.4% for etoposide plus cisplatin and 69.0% for irinotecan plus cisplatin, with a hazard ratio of 1.076 (95% CI, 0.666 to 1.738; one-sided log-rank P = .619). Grade 3-4 adverse events were more frequent in the etoposide plus cisplatin arm, with febrile neutropenia (20% of 109 patients v 4% of 107 patients) and neutropenia (97% v 36%) being the most common. Meanwhile, grade 3-4 anorexia (6% v 11%) and diarrhea (1% v 8%) were more frequently observed in the irinotecan plus cisplatin arm. CONCLUSION Irinotecan plus cisplatin is not superior to etoposide plus cisplatin for improving RFS in patients with completely resected HGNEC; thus, etoposide plus cisplatin remains the standard treatment.

Download Full-text