Cervical cancer in 2002 (n=500,000) (Developed and developing countries)
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Transcript of Cervical cancer in 2002 (n=500,000) (Developed and developing countries)
Trial Concept Weekly VS Three Weekly Chemotherapy for Chemoradiation in Cervical Cancer
Dr Sarikapan Wilailak** Endorsed by the TGCS (Thai Gynecologic Cancer Society)
Cervical cancer in 2002 (n=500,000)(Developed and developing countries)
DEVELOPED COUNTRIES DEVELOPING COUNTRIES
SITEAttrib to HPV (%)
TOTAL cancers
Attrib to HPV
% all cancer
TOTAL cancers
Attrib to
HPV
% all cancer
CERVIX 100 83,400 83,400 1.7% 409,400 409,400 7.0%
Ferlay J et al. Globocan 2002. IARC 2004.
Cancer in Thailand, Vol.IV, 1998-2000: 2007
New cases / year: 6,243 New cases / year: 6,243
Deaths / year: 2,620 Deaths / year: 2,620
In Thailand, each day 7 women die from cervical
cancer
In Thailand, each day 7 women die from cervical
cancer
Ferlay J et al. Globocan 2002. IARC 2004
Concurrent chemoradiation
In 1999, the USNCI issued a statement that concurrent chemoradiation should be considered for all patients with advanced cervical cancer (based on 5 RCT: and recently Keys et al, Marris et al., Rose et al., Whitney et al., Peters et al.)
Meta analysis
of Concurrent Chemo RT
vs RT(18 RCT)
Chemoradiotherapy for cervical cancer meta-analysis collaboration. ‘J Clin Oncol 2008:26:5802-12
Nowadays, concurrent chemoradiation has become the gold standard treatment for locally advanced cervical cancer.
Weekly cisplatin
VS
Three weekly cisplatin
Weekly VS three weekly
Three weekly chemotherapy could save a considerable amount of resources
There has been no randomized study that compares the two types of chemotherapeutic administration mentioned.
Weekly VS three weekly
The question of interest in this proposal is whether weekly or three weekly chemotherapy for chemoradiation in locally-advanced cervical cancer is comparable in terms of efficacy, toxicities, and cost effectiveness.
Objectives
Primary objectives will be to determine: Progression-free survival Acute toxicities Cost effectiveness of the treatments
Secondary objectives will be to determine: Overall survival long-term toxicities Patterns of disease recurrence Acceptability of patients Patients’ quality of life
Inclusion criteria Stage IB2 to IVA Squamous and adenocarcinoma ECOG performance status 0-2 WBC ≥ 3.0 x 109/L and ANC ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L Bilirubin ≤ 1.5 x UNL AST/ALT ≤ 2.5 x UNL Adequate renal function: creatinine ≤ 1.5 ? or
calculated creatinine clearance (CockCroft-Gault Formula) ≥60ml/min
No contraindication to the use of cisplatin Informed consent
Exclusion criteria High-risk histologies (adenosquamous, clear cell
etc) Neoadjuvant chemotherapy Previous pelvic radiotherapy Patients with other invasive malignancies, with the
exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
Pregnancy Serious illness or medical condition that precludes
the safe administration of the trial treatment HIV positive
Study Design and procedure
multi-centre randomized phase III trial. Arm A: Weekly chemoradiation Arm B: Three weekly chemoradiation Standard radiation treatment will be given
in both arms The overall treatment time should not
exceed eight weeks.
In arm A, cisplatin will be given during the radiation at a dose of 40mg/m2 weekly for 6 doses, within 4 weeks of completion of all radiation treatment.
In arm B, cisplatin will be given during the radiation at a dose of 70mg/m2 three weekly for 3 doses, within 4 weeks of completion of all radiation treatment.
Outcomes
Primary outcomes: Progression-free survival rates Acute toxicity rate Cost effectiveness ratio of the treatments
Secondary outcomes: Overall survival rates long-term toxicity rate Patterns of disease recurrence Acceptability rate of patients Patients’ quality of life score