Purpose
To evaluate tolerability and tumour response of a new regimen delivering intensive chemotherapy and radiotherapy in an interdigitating manner.
(ClinicalTrials.gov Identifier: NCT00422864)
Methods and Materials
This was a single-arm prospective study for patients with untreated simultaneous primary and metastatic rectal cancer.
FOLFOX chemotherapy (oxaliplatin 100mg/m2 day 1,
leucovorin 200mg/m2 day 1,
5FU 400mg/m2 bolus day 1,
then C.I.
2.4g/m2 over 46h) was given in week 1,
6,
and 11.
Pelvic radiotherapy (25.2Gy in 3 weeks in 1.8Gy/fr with concurrent oxaliplatin 85mg/m2 day 1 and 5FU C.I.
200mg/m2/day) was given in week 3-5,
and week 8-10.
Patients received 3 courses of FOLFOX and pelvic chemoradiation 50.4 Gy in 12 weeks.
All...
Results
Twenty-six patients were accrued.
The mean age was 61 (range 33-82) years.
69% were male.
MRI-stage of the rectal primary was T2 4%,
T3 81% and T4 15%.
Liver,
lung,
and extra-pelvic nodal metastases were present in 81%,
35% and 23% of patients,
respectively.
38% of patients had multiple sites of metastatic disease.
92% (95% CI:75%-99%) completed the 12-week treatment regimen.
All patients received the planned radiation dose.
65% (95% CI:44%-83%) received the planned number of courses of oxaliplatin with 88% receiving at least 75%...
Conclusion
Intensive chemotherapy and radiotherapy can be delivered simultaneously in this manner.
High completion and response rates are encouraging.
This regimen is the subject of a current phase II neoadjuvant trial.
(TROG 09.01).
Personal Information
S.
Ngan1,2,
J.
McKendrick3,4,
M.
Bressel1,
T.
Leong1,2,
J.
Mackay1,2,
S.
Chander1,
A.
Heriot1,2,
M.
Steel3,
J.
Chu1,
M.
Jefford1,2,
B.
McClure1,
M.
Michael1,2
1Peter MacCallum Cancer Centre,
Melbourne,
Victoria,
Australia
2The University of Melbourne,
Parkville,
Victoria,
Australia
3Box Hill Hospital,
Box Hill,
Victoria,
Australia
4Monash University,
Clayton,
Victoria,
Australia
