Balloon catheter hypoxic pelvic perfusion with mitomycin C and melphalan for locally advanced tumours in the pelvic region: a phase I-II trial.
OBJECTIVE
To investigate the feasibility of hypoxic pelvic perfusion (HPP), using balloon catheter techniques as treatment modality for locally advanced pelvic malignancies.


METHODS
In a phase I--II study, 16 patients with various non-resectable pelvic tumours were treated with two HPP with MMC and melphalan, followed by radiotherapy (25 Gy) and surgical resection if feasible. Toxicity and procedure related complications were documented. Tumour responses were assessed by MRI or CT. Pain reductive effects were assessed by evaluation of pain registration forms.


RESULTS
HPP resulted in augmented regional drug concentrations with relatively low systemic levels. Some severe systemic toxicity was observed. One procedure related death occurred. Pain reduction effects were short-lived. Ten patients had radiological NC, two PD and one PR. In 11 patients surgical resection was performed, which was microscopically radical in six cases. Mean survival was 26.8 months (range 1--86).


CONCLUSIONS
The seemingly favorable pharmacokinetic profiles observed with HPP in this and other studies can still lead to severe systemic toxicity. In terms of survival, local (re-)recurrence and pain reduction there seems no benefit of addition of HPP to pre-operative radiotherapy. HPP with MMC and melphalan, does not seem a therapeutic option in patients with locally advanced pelvic tumours.
van Ijken
M G A
MG
Department of Surgical Oncology, Erasmus Medical Center Rotterdam, Daniel den Hoed Cancer Center, Groene Hilledijk 301, 3075 EA Rotterdam, The Netherlands.
van Etten
B
B
Guetens
G
G
de Bruijn
E A
EA
Ten Hagen
T L M
TL
Wiggers
Th
T
Eggermont
A M M
AM
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D002404:Catheterization / Q000379:methods*; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008558:Melphalan / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D016685:Mitomycin / Q000009:adverse effects / Q000627:therapeutic use*; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D010147:Pain Measurement; D010386:Pelvic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D011879:Radiotherapy Dosage; D012074:Remission Induction; D015996:Survival Rate; D014057:Tomography, X-Ray Computed
D000903:Antibiotics, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D016685:Mitomycin; D008558:Melphalan