Phase I study of chemoradiation with nedaplatin and ifosfamide in patients with advanced squamous cell carcinoma of the uterine cervix

2008 ◽  
Vol 18 (6) ◽  
pp. 1300-1304 ◽  
Author(s):  
J. Kodama ◽  
M. Takemoto ◽  
N. Seki ◽  
K. Nakamura ◽  
A. Hongo ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Uterine Cervix ◽  
Complete Response ◽  
Advanced Squamous Cell Carcinoma ◽  
Alive With Disease ◽  
Disease Free ◽  
Dose Limiting Toxicity

Cisplatin and ifosfamide are considered among the most active drugs in both neoadjuvant and salvage treatments for patients with cervical cancer. Nedaplatin is an analog of cisplatin and it exhibits lesser nephrotoxicity, neurotoxicity, and gastrointestinal toxicity than cisplatin. This study aimed to determine the recommended dosage of nedaplatin plus ifosfamide chemoradiotherapy for advanced squamous cell carcinoma (SCC) of the uterine cervix. Beginning with a dose of 65 mg/m2, nedaplatin (day 1) combined with ifosfamide 1 g/m2 (days 1–5) was designed to be administered for three cycles (minimum: two cycles); its dose was gradually escalated up to 80 mg/m2. Dose-limiting toxicity (DLT) was defined as a more than 7-day delay in the planned radiation therapy and/or planned chemotherapy (prior to the completion of two cycles) due to toxicity. Chemotherapy was not interrupted prior to the completion of two cycles in any patients. Of the 12 patients, 11 received three cycles of chemotherapy. DLT did not occur in any patient. We confirmed a clinical complete response (CR) in ten and partial response (PR) in two patients. The median follow-up period was 39 months (range: 18–57 months). Ten patients (83%) were alive and disease free, one patient was alive with disease, and only one patient died due to the disease. Nedaplatin and ifosfamide combination chemotherapy is a feasible and active chemoradiation strategy for patients with advanced SCC of the uterine cervix. With the ifosfamide dose fixed to 1 g/m2, the recommended nedaplatin dosage was determined to be 80 mg/m2 to be administered for three cycles.

Follow-up of concomitant treatment with gemcitabine/radiotherapy in locally advanced squamous cell carcinoma of head and neck

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15537-15537
Author(s):  
F. Bustamante ◽  
R. Villalobos ◽  
E. Castillo ◽  
A. Calva ◽  
F. Gallegos ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Partial Response ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Complete Response ◽  
Concomitant Treatment ◽  
Advanced Squamous Cell Carcinoma

15537 Background: The stages of the locally advanced head and neck cancer have a negative prognosis, therefore, new treatments are continuously explored. One of these treatments consists of the use of Gemcitabine concomitant with radiotherapy. We previously evaluated the rate of response and the toxicity profile of this treatment in 15 patients and now we are reporting the follow up of such study. Methods: Fifteen patients, with histological report of locally advanced squamous cell carcinoma of head and neck, initiated treatment of Gemcitabine at intravenously doses of 50 mg\m2 per application weekly concomitant with radiotherapy. The radiotherapy consisted of an initial photons dose of 3960 cGy in 22 fractions of 180 cGy to the primary site and regional lymph with posterior increments of 2880 cGy in 16 fractions of 180 cGy excluding the spinal cord and electrons increments if necessary. Results: In 9 of the 15 patients complete response was obtained, achieving organ preservation. Four of the 15 patients presented a partial response and two presented progression. The principal severe toxicity presented was mucositis. The mean follow-up is 23 months with a range of 19–27 months. From the 9 patients that presented a complete response, one presented bone recurrence 13 months after achieving the total response; another one of them died because an infectious process without evidence of tumoral activity. The rest 7 patients are to the present date without evidence of tumoral activity. One of the patients with partial response is still alive with tumoral activity in central nervous system. The remaining patients died due to tumoral activity. Conclusions: In our study with 15 patients an overall response of 87% was obtained. With a follow up to 23 months only one recurrence has been presented. We concluded that the treatment is feasible and it could have an impact in the overall survival but studies with a greater number of patients and a larger follow up are needed. No significant financial relationships to disclose.

A phase II evaluation of mitolactol in patients with advanced squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study.

1989 ◽  
Vol 7 (12) ◽  
pp. 1892-1895 ◽  
Author(s):  
F B Stehman ◽  
J A Blessing ◽  
R McGehee ◽  
R J Barrett
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Gynecologic Oncology ◽  
Complete Response ◽  
Gynecologic Oncology Group ◽  
Advanced Squamous Cell Carcinoma ◽  
Level Of Activity ◽  
Life Threatening ◽  
Tolerable Dose

Sixty patients with advanced squamous cell carcinoma of the cervix (SCC) who had received no prior chemotherapy were entered onto a study of mitolactol (dibromodulcitol [DBD]). The drug was administered orally at an initial dose of 180 mg/m2 per day for 10 days and repeated every 4 weeks. There were 55 evaluable patients, of whom one (2%) had a complete response (CR), and 15 (27%) had a partial response (PR), (CR plus PR, 29%). A 95% confidence interval for the true response rate is 18.8% to 42.1%. Myelosuppression was appreciable at this dose and schedule, with 13 patients experiencing life-threatening thrombocytopenia and two drug-related deaths. The level of activity in this disease encourages us to determine a tolerable dose of this drug in combination with cisplatin for further study.

Role of chemoradiotherapy alone in the management of unfit patients with nonmetastatic locally advanced squamous cell carcinoma of the esophagus.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 138-138
Author(s):  
A. Pisa ◽  
I. Moya ◽  
C. Pericay ◽  
E. Dotor ◽  
J. Alfaro ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Surgical Procedures ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Advanced Squamous Cell Carcinoma ◽  
Carcinoma Of The Esophagus

138 Background: Surgery is considered the best treatment for patients (pts) with non-metastatic locally advanced squamous cell carcinoma of the esophagus who have responded to neoadjuvant chemoradiotherapy (CRT) in terms of locoregional control. However, in these pts PFS and OS have not been proved superior to those achieved by CRT alone. Besides, the addition of surgery to CRT increases treatment-related morbidity and mortality. Unfit pts are usually declined for surgical procedures and included in definitive CRT programs. The aim of this study was to define the role of non-surgical strategies (CRT, CT or RT) in unfit pts considered non-optimal for surgical procedures. Methods: We retrospectively reviewed 90 pts with squamous cell carcinoma of the esophagus who had been diagnosed and treated at our institution from January 2004 to December 2009. Fifty-one pts were non-metastatic among which 19 underwent surgery and 32 a non-surgical procedure (CRT, CT, RT or BSC). Our aim was to identify OS, PFS, RR, data on comorbidity and toxicity in these 32 pts. Results: Thirty out of the 32 pts were men with a median age of 62 years (range 41-90). Comorbidity was detected in 17 pts (53%) as means of respiratory disorders (21.9%), cardiopathy (12.5%), hepatopathy (21.9%), synchronic tumors (25%) and metachronic tumors (25%). Seventeen pts received CRT, 7 received CT, 1 received RT and 7 received BSC alone (53%, 22%, 3% and 22% respectively). Grade 3 and 4 toxicities were observed in 15 pts (46.9%) as means of mucositis (18.8%), oesophagitis (15.6%), diarrhoea (12.5%) and neutropaenia (12.5%). One patient in the CRT group died of toxicity. RR was 43.8% (70.6% for CRT, 14.3% for CT alone). Median follow-up was 17.2 months. Median PFS was 11.3 ± 6.12 months (17.9 for CRT, 5.1 for CT alone). Median OS was 15.6 ± 7.6 months (6.9 for CT alone). Conclusions: Our experience with CRT alone in unfit pts with locally advanced squamous cell carcinoma of the oesophagus supports its use with a median PFS of 17.9 months and controllable toxicity. Data on median OS are lacking due to pending long-term follow-up. No significant financial relationships to disclose.

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