Results of a European Organization for Research and Treatment of Cancer/Early Clinical Studies Group Phase II Trial of First-Line Irinotecan in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Cervix

1999 ◽  
Vol 17 (10) ◽  
pp. 3136-3142 ◽  
Author(s):  
Catherine Lhommé ◽  
Pierre Fumoleau ◽  
Pierre Fargeot ◽  
Yvan Krakowski ◽  
Véronique Dieras ◽  
...  

PURPOSE: To determine the efficacy and tolerability of irinotecan (CPT-11) in advanced or recurrent cervical carcinoma. PATIENTS AND METHODS: Eligible patients had histologically confirmed, inoperable, progressive, metastatic or recurrent squamous cell cervical carcinoma and had received no radiotherapy in the preceding 3 months and had never received chemotherapy. The initial irinotecan dosage of 350 mg/m2 every 3 weeks was modifiable according to toxicity. Treatment continued for six cycles after complete response, or until disease progression or excessive toxicity after partial response, or for three additional cycles in the case of stable disease. Patients were stratified into group A (≥ one measurable lesion in a previously unirradiated area, with or without progressive disease in irradiated fields) or group B (measurable new lesion[s] in an irradiated field). RESULTS: Fifty-one of 55 enrolled patients were eligible for inclusion (median age, 47 years; range, 30 to 71 years). The response rate was 15.7% (95% confidence interval [CI], 7.0% to 28.6%) overall, 23.5% (95% CI, 10.7% to 41.2%) for group A (complete response, 2.9%), and zero for group B. The median time to progression and median survival were 4.0 and 8.2 months for group A and 2.5 and 4.2 months for group B, respectively. The major grade 3/4 toxicities for groups A and B were diarrhea (24.3% and 55.5%, respectively) and neutropenia (24.3% and 33.3%, respectively). There were four toxicity-related deaths, three in group B. Patients with no prior external pelvic irradiation experienced fewer grade 3 and 4 adverse events. CONCLUSION: Irinotecan is effective in treating cervical squamous cell carcinoma if disease is located in an unirradiated area. Because of toxicity, a reduced dose is advised for patients previously treated with external pelvic irradiation.

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 15-15
Author(s):  
Shah-Hwa Chou ◽  
Yu-Wei Liu

Abstract Background Enhanced recovery after surgery (ERAS) was originally designed and used in colorectal surgery. Recently there were some related reports of its implementation on esophageal cancer surgery, mainly adenocarcinoma. This study is to determine if ERAS can be effectively and safely applied to esophageal squamous cell carcinoma in Asian population. Methods In early 2012, our perioperative management protocol was reinvented and has been implemented thereafter. So two groups of patients were set up and compared. Group A is the patients operated on before 2012, managed by the old protocol. Group B is the patients managed under the new protocol. Their demographics, complications, hospital stay and charges were reviewed and analysed. Results Group A 65 patients. Group B 61 patients. The ventilator days, ICU stay and postoperative stay were statistically shorter in group B. There was no hospital mortality in either groups. No increase of complications was noted in group B. The hospital charges in group B were lower although statistically insignificant. Conclusion The new protocol of perioperative care is safe and effectively enhanced the postoperative recovery after esophagectomy and reconstruction for esophageal squamous cell carcinoma. Table 1. Clinical protocol for group A and B POD, post-operative day; ICU, intensive care unit; TPN, total parenteral nutrition; J-P drain, Jackson-Pratt drain; N/S, normal saline; CVC, central venous catheter; NG, nasogastric tube; OR, operating room; NPO, nil per os; IV, intravenous; PCA, patient control analgesia. Disclosure All authors have declared no conflicts of interest.


2020 ◽  
Vol 2020 ◽  
pp. 1-8 ◽  
Author(s):  
Diana A. Martínez B. ◽  
Paola Andrea Barato Gómez ◽  
Carlos Arturo Iregui Castro ◽  
Jaiver E. Rosas Pérez

Objectives. To investigate the effect of systemic administration of the immunosuppressant dexamethasone (DM) while inducing hamster buccal pouch DMBA carcinogenesis. Materials and Methods. Two different experiments were performed. In the first experiment, hamsters’ right buccal pouches in group A (n = 10) were painted three times per week with 7,12-dimethylbenzanthracene (DMBA) 0.5%, while pouches of animals in group B (n = 4) were painted with mineral oil only. Two animals were sacrificed every three weeks to obtain histological samples and to evaluate pathological abnormalities. After 12 weeks of exposition and with no macroscopic evidence of neoplasms, dexamethasone DM (1 mg/kg) was administered daily for 7 days to the last two animals in the study. In the second experiment, DM was administered since DMBA exposition, following the same protocol as the first experiment. Results. The time of macroscopic neoplasm development was reduced when DM-DMBA coexposition was employed, finding tumors after 10–12 weeks of exposition. In addition, the frequency of histopathological lesions was higher. Conclusion. Immunomodulatory action of dexamethasone may reduce the time of oral squamous cell carcinoma (OSCC) induction and may increase the incidence of neoplasms developed.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18512-e18512
Author(s):  
Bruna Bighetti ◽  
José Tristão Neto ◽  
Renata do Socorro Monteiro Pereira ◽  
LAÍS CRISTHINE SOUZA ◽  
Ilka Lopes Santoro ◽  
...  

e18512 Background: Cisplatin-based chemoradiotherapy (CRT) is a well-established regimen used for adjuvant and/or head-and-neck squamous cell carcinoma (HNSCC) radical treatment. The most classic protocol for chemoradiotherapy remains the administration of Cisplatin 100mg/m² EV D1 q3-week period, 3 cycles. The objective of this study is to assess the efficacy and tolerability of the weekly 40mg/m² cisplatin regimen. Methods: we conducted a retrospective study from 2007-2020 with 102 patients treated at a national reference institution. All of them with HNSCC received concurrent CRT with weekly cisplatin 40mg/m² EV D1. We analyzed the overall survival (OS), local recurrence and tolerability in this scheme. Results: The median cisplatin cumulative dose received by our patients was 240mg/m². Hence, we divided them in two groups for the analysis: Group A (41 patients) received less than 240mg/m² cisplatin total dose and Group B (61 patients) received more or equal 240mg/m² cisplatin total dose. Both groups were equally balanced between sex, clinic stage, histologic grade and clinic status. We found that the Group A experienced 5 deaths (12.2%) while the Group B experienced 6 deaths (9.8%). The mean time to recurrence disease in the Group A was 45.68 months and in Group B 60.22 months (p = 0.958). The estimated overall survival in the Group A was 150 months and in the Group B was 116.4 months (p = 0.443). Conclusions: The weekly cisplatin dose regimen showed to be feasible, more tolerable, and less toxic and with no difference in terms of OS then the classic 3-week cisplatin protocol in the CRT setting. Our group suggests that the 240mg/m² cumulative cisplatin weekly schedule should be a better option for CRT treatments then the classic cisplatin regimen. A phase III clinical trial is warranted to further understanding of this framework. Key-words: head and neck cancer, cisplatin, radiotherapy


OTO Open ◽  
2021 ◽  
Vol 5 (3) ◽  
pp. 2473974X2110452
Author(s):  
Katsunori Katagiri ◽  
Kiyoto Shiga ◽  
Daisuke Saito ◽  
Shin-ichi Oikawa ◽  
Aya Ikeda ◽  
...  

Objective To examine the safety and efficacy of concomitant chemoradiotherapy using a modified TPF regimen (docetaxel + cisplatin + 5-fluorouracil) in patients with advanced sinonasal squamous cell carcinoma (SNSCC). Study Design Retrospective study. Setting Tertiary center (university hospital). Methods Seven patients with previously untreated T3-T4 SNSCC were enrolled. They underwent radiotherapy once daily (total dose, 70 Gy) with 2 courses of concomitant 120-hour infusion of 5-fluorouracil (600 mg/m2/d), docetaxel (50 mg/m2, day 2), and cisplatin (60 mg/m2, day 2) Results Grade 4 leukopenia, grade 4 neutropenia, and grade 3 lymphopenia were observed in 1, 3, and 4 patients, respectively. Grade 4 creatinine elevation was observed in 1 patient. However, other grade 3 or 4 adverse events were not common. Complete response was obtained in all patients. At 60 months there was 85.7% disease-free survival and 100% overall. Conclusion Concomitant chemoradiotherapy with a modified TPF regimen may be feasible and effective in patients with advanced SNSCC.


1999 ◽  
Vol 17 (9) ◽  
pp. 2915-2915 ◽  
Author(s):  
Atsushi Ohtsu ◽  
Narikazu Boku ◽  
Kei Muro ◽  
Keisho Chin ◽  
Manabu Muto ◽  
...  

PURPOSE: To investigate the efficacy and feasibility of concurrent chemoradiotherapy for locally advanced carcinoma of the esophagus. PATIENTS AND METHODS: Fifty-four patients with clinically T4 and/or M1 lymph node (LYM) squamous cell carcinoma of the esophagus were enrolled. Patients received protracted infusion of fluorouracil 400 mg/m2/24 hours on days 1 to 5 and 8 to 12, 2-hour infusion of cisplatin 40 mg/m2 on days 1 and 8, and concurrent radiation therapy at a dose of 30 Gy in 15 fractions over 3 weeks. Filgrastim was prophylactically administered to 35 patients. This schedule was repeated twice every 5 weeks, for a total radiation dose of 60 Gy, followed by two courses of fluorouracil (800 mg/m2/24 hours for 5 days) and cisplatin (80 mg/m2 on day 1). RESULTS: There were 21 patients with T4M0 disease, one with T2M1 LYM, 17 with T3M1 LYM, and 15 withT4M1 LYM. Forty-nine patients (91%) completed at least the chemoradiotherapy segment. The 18 patients (33%) who achieved a complete response included nine (25%) of the 36 with T4 disease and nine (50%) of the 18 with non-T4 disease. Major toxicities were leukocytopenia and esophagitis; there were four (7%) treatment-related deaths. Prophylactic filgrastim reduced the incidence of grade 3 or worse leukopenia without improving dose-intensity or response. With a median follow-up duration of 43 months, median survival time was 9 months. The 3-year survival rate was 23%. CONCLUSION: Despite its significant toxicity, this combined modality seemed to have curative potential even in cases of locally advanced carcinoma of the esophagus.


Cancers ◽  
2021 ◽  
Vol 13 (24) ◽  
pp. 6373
Author(s):  
Giorgia Garganese ◽  
Frediano Inzani ◽  
Simona Maria Fragomeni ◽  
Giulia Mantovani ◽  
Luigi Della Corte ◽  
...  

Introduction: The study’s aim was to investigate the immunohistochemical (IHC) expression of biological markers as potential prognostic/therapeutic factors in vulvar squamous cell carcinoma (VSCC). Methodology: A series of 101 patients surgically treated at our center from 2016 to 2020 were retrospectively enrolled: 53 node-negative (Group A) and 48 node-positive (Group B). A total of 146 samples, 101 from primary tumor (T) and 45 from nodal metastases (N), were investigated. The IHC panel included: p16, p53, MLH1, MSH2, MSH6, PMS2, PD-L1, CD3, HER2/neu, ER, PR, EGFR, VEGF, and CD31. The reactions were evaluated on qualitative and semi-quantitative scales. Generalized Linear Model (GLM) and cluster analysis were performed in R statistical environment. A distance plot compared the IHC panel of T with the correspondent N. Results: In Group A: p16-positive expression (surrogate of HPV-dependent pathway) was significantly higher (20.8% vs. 6.2%, p = 0.04). In Group B: PD-L1 positivity and high EGFR expression were found, respectively, in 77.1% and 97.9% patients (T and/or N). Overall, p16-negative tumors showed a higher PD-L1 expression (60.9% vs. 50.0%). In both groups: tumoral immune infiltration (CD3 expression) was mainly moderate/intense (80% vs. 95%); VEGF showed strong/moderate-diffuse expression in 13.9% of T samples; CD31, related to tumoral microvessel density (MVD), showed no difference between groups; a mutated p53 and over-expressed PD-L1 showed significant association with nodal metastasis, with Odds Ratios (OR) of 4.26 (CI 95% = 1.14–15.87, p = 0.03) and 2.68 (CI 95% = 1.0–7.19, p < 0.05), respectively; since all mismatch repair proteins (MMR) showed a retained expression and ER, PR, and HER2/neu were negative, they were excluded from further analysis. The cluster analysis identified three and four sub-groups of molecular profiles, respectively, in Group A and B, with no difference in prognosis. The molecular signature of each N and corresponding T diverged significantly in 18/41 (43.9%) cases. Conclusions: Our results support a potential role of immune checkpoint inhibitors and anti-VEGF and anti-EGFR drugs especially in patients with worse prognosis (metastatic, HPV-independent). A panel including EGFR, VEGF, PDL1, p16, and p53 might be performed routinely in primary tumor and repeated in case of lymph node metastases to identify changes in marker expression.


2021 ◽  
Author(s):  
Xiaobo liu ◽  
Ziye Gao ◽  
Wen Xu ◽  
JianChao Meng ◽  
Chuantao Sun ◽  
...  

Abstract Objective: This study aimed to compare the differences in microbiota between the postoperative tissues and esophageal mucosa tissues of patients with esophageal squamous cell carcinoma (ESCC). Methods: Seventy-two patients who had ESCC and diagnosed in Taihe Hospital were selected from July 2018 to July 2019 to participate in this work. Then, 27 postoperative tissues and 45 mucosa samples of ESCC were collected. The sequence V4 hypervariable region was amplified, and Illumina MiSeq sequencing was performed to analyze the differences between the two groups. Results: Results revealed that the Shannon and Chao1 indices of the postoperative esophageal cancer tissue group (Group A) were significantly higher (P<0.05) than those of the esophageal mucosa group (Group B). The Simpson index of Group A was higher than that of Group B, but the difference was not significant (P>0.05). The beta diversity of the two groups was also not significantly different (P>0.05). LEfSe analysis showed that the abundance of Megasphaera, Actinobacteria, Enterobacteriaceae, and Enterobacteriales in Group A was significantly higher than that in Group B, but the abundance of Mogibacteriaceae in Group B was significantly higher than that in Group A (P<0.05). At the phylum level, Actinobacteria and Verrucomicrobiae were more abundant in the postoperative tissue group than in the esophageal mucosa group. The abundance of Fusobacteriia, SR1, and Spirochaetes in the postoperative tissue group was significantly lower than that of the esophageal mucosa group(P<0.05). Conclusion: The source of the sample should be considered in studies on the esophageal flora. More relevant findings were obtained from postoperative tissues than from the normal mucosa.


1998 ◽  
Vol 16 (4) ◽  
pp. 1325-1330 ◽  
Author(s):  
D M Shin ◽  
B S Glisson ◽  
F R Khuri ◽  
L Ginsberg ◽  
V Papadimitrakopoulou ◽  
...  

PURPOSE To assess the activity and toxicity profile of combined taxol (paclitaxel), ifosfamide, and platinum (cisplatin) (TIP) in patients with recurrent or metastatic squamous cell carcinoma (SCC) of the head and neck. PATIENTS AND METHODS Recurrent or metastatic head and neck SCC patients received paclitaxel 175 mg/m2 in a 3-hour infusion on day 1; ifosfamide 1,000 mg/m2 in a 2-hour infusion on days 1 through 3; mesna 600 mg/m2 on days 1 through 3; and cisplatin 60 mg/m2 on day 1, repeated every 3 to 4 weeks. All were premedicated with dexamethasone, diphenhydramine, and cimetidine. Prophylactic hematopoietic growth factors were not permitted. RESULTS Fifty-two patients were assessable for response and toxicity; 53 for survival (local-regional recurrence alone in 57% and distant metastasis with or without local-regional recurrence in 43%). Overall response rate was 58% (30 of 52) of patients; complete response rate was 17% (nine of 52) of patients, with six complete responses that continued for a median 15.7+ months. Median follow-up of all patients was 17.7 months. Median survival was 8.8 months (95% confidence interval [CI] 8.1 to 17.5 months). Toxicity was relatively well tolerated and caused no deaths. The most frequent moderate-to-severe toxicity (90% of patients) was transient grades 3 to 4 neutropenia; neutropenic fever occurred in 27%. Grade 3 peripheral neuropathy occurred in three patients, none had grade 4. Grade 3 mucositis occurred in only one patient, none had grade 4. CONCLUSION TIP had major activity in this setting, with a 58% objective response rate, 17% complete response rate, durable complete responses (six of nine persisting), and relatively well-tolerated toxicity, with no toxic deaths. The activity of TIP, a novel taxol-cisplatin-based regimen, in recurrent or metastatic head and neck SCC should be confirmed in a phase III trial.


2019 ◽  
Vol 6 (8) ◽  
pp. 2761
Author(s):  
S. R. Kulkarni ◽  
Yogesh Prakash Garud

Background: One of the major health problems in the world is cancer. More than 11 million people are diagnosed yearly with cancer. Oral cancer is one of the deadliest cancers. Oral cancer is generally preceded by precancerous lesions. India has highest number of oral cancer patients. β2 microglobulin (β2 m) is one of the tumor markers.Methods: We are correlating serum levels of beta 2 microglobulin in leukoplakia and oral squamous cell carcinoma. In our study, the serum β2 m levels were estimated in 2 groups of 30 subjects each with oral squamous cell carcinoma (OSCC) designated as Group A, 30 subjects with oral leukoplakia designated as Group B.Results: There were majority of participants from age group of 51 to 70 years (Group A-60%, Group B-53.33%). Group A had majority of females 20 (66.67%) while males were 10 (33.33%). Group B had majority of males 18 (60.00%) while females were 12 (40.00%). Major adverse habit was tobacco chewing (83.33% Group A and 73.33% in group B). Most common site was Left BM. Right BM was second. There was significant association between the groups and serum β2 m levels. Mean levels of Group A patients were 3.13±0.47 mg/L and Group B 1.43±0.29 mg/L.Conclusions: Adverse habits like tobacco chewing, smoking and alcohol increase chances of oral cancers and precancerous lesions. Significant correlation between oral cell carcinoma cases and serum β2 m levels is seen.


2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Adity Chakraborty ◽  
Abhinandan Bhattacharjee ◽  
Amlan Jyoti Nath ◽  
Shibashis Deb ◽  
Aakanksha Rathor

Abstract Background Cisplatin is a frontline anticancer drug routinely used as part of concurrent chemoradiation administered at 3-weekly (100 mg/m2) dose. However, its role as fractionated weekly dose has achieved favorable outcome in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN) during induction chemotherapy (IC). We therefore sought to compare the toxicity outcomes of patients with LA-SCCHN treated with platinum-based IC at a single institution study using split-dose cisplatin chemotherapy. We compared the hematological and renal toxicity profile between the weekly cisplatin (30 mg/m2) (group A) versus 3-weekly (100 mg/m2) (group B) dosage schedule in this setting. Results The median age of the patients in groups A and B were 49.1 years and 48.27 years respectively with male:female ratio of 4:1. Most of the patients were of oropharyngeal cancers. Group A patients showed greater neutropenia (40.2%) than group B (20.6%). There was statistically significant fall in Hb% level in group A (13.9%) than in group B (11.9%). Renal profile showed greater rise in serum urea and serum creatinine (52.7%) in group B than in group A (52.29%) with statistically significant difference. Conclusions Since toxicities induced by high-dose cisplatin are irreversible and reduce quality of life in patients, the weekly regimen may be preferred owing to less renal toxicity, lesser hospitalization and more feasible in situations with high patient load and limited resources.


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