Weekly cisplatin 20 mg/m2 in patients with carcinoma of cervix receiving pelvic radiotherapy at Srinagarind Hospital: a randomized controlled trial.
OBJECTIVE
To evaluate treatment response and acute treatment-related toxicity of concurrent chemoradiotherapy with cisplatin 20 mg/m2 , compared to 40 mg/m2 as the standard, in locally advanced cervical cancer.


METHODS
A prospective randomized controlled trial in Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen.


METHODS
140 patients, >60 years old with biopsy-proven previously untreated invasive carcinoma of cervix, FIGO stage IB2-IVA, undergoing concurrent chemoradiotherapy with adequate bone marrow, renal and liver functions, between April and December 2009.


METHODS
All patients were randomly assigned (half in each group)to receive weekly cisplatin at a dose of 40 mg/m2 compared to 20 mg/m2, concurrent with radiotherapy for 6 cycles. Main outcome measures included clinical response, cytological response, and acute treatment-related toxicity.


RESULTS
All 140 patients completed 6 cycles of weekly cisplatin. 80% had squamous cell carcinomas; about half were FIGO stage IIIB. The 40 mg/m2 group showed unplanned interruptions in 13/70 (18.6%), which was significantly different from the 5/70 (7.1%) in the 20 mg/m2 group (p=0.02), resulting in prolonged treatment time (p=0.026). Complete responses were found in 69/70 (98.6%) and 68/70 (97.1%), respectively, with no significant difference. Hematological and gastrointestinal toxicities were most frequently observed. Acute toxicities in the first group was significantly higher when compared to the second group (p<0.05) as follows; grade 1-2 leukopenia (14.8% vs. 6.4%), grade 1-2 neutropenia (9.3% vs. 2.6%), grade 2 N/V (3.8% vs. 1%), grade 2 diarrhea (2.4% vs. 0.7%), and grade 1 sensory neuropathy (4.5% vs. 1.2%). No treatment related deaths were encountered.


CONCLUSIONS
This prospective trial has sufficient data to support the conclusion that concurrent chemoradiotherapy with weekly cisplatin 40 mg/m2 in locally advanced cervical cancer gives good treatment outcomes. When reducing the cisplatin dose to 20 mg/m2, treatment responses were still comparable to the standard, but acute toxicity could be reduced. However, there are insufficient data to assess long term treatment outcomes and late treatment related toxicity, because of the short follow-up time.
Punushapai
Utumporn
U
Gynecologic Oncology Division, Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand. doctor.utum@gmail.com
Yuenyao
Pissamai
P
Chumworathayi
Bandit
B
Luanratanakorn
Sanguanchoke
S
Udomthavornsuk
Banchong
B
D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D002945:Cisplatin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D010386:Pelvic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D015996:Survival Rate; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
D000970:Antineoplastic Agents; D002945:Cisplatin