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Annals of Oncology
intrathorasic extensions. Complications described in the literature are minimised.
Superior cosmetic results compared to Kocher’s technique.
Disclosure: All authors have declared no conflicts of interest.
1061TiP FIRST-IN-MAN PHASE I STUDY OF TPCS2A-BASED
PHOTOCHEMICAL INTERNALISATION (PCI) OF
BLEOMYCIN IN LOCALLY RECURRENT OR ADVANCED/
METASTATIC, CUTANEOUS OR SUBCUTANEOUS
MALIGNANCIES
M. Forster, A. Sultan, W. Jerjes, C. Simeon, S. Morley, D. Carnell, C. Hopper
Head and Neck, University College London Hospital, London,
UNITED KINGDOM
Objective: PCI is a novel technique in which chemotherapeutic cytotoxicity is
enhanced with a photosensitiser and light exposure. This dose-escalation study
assessed the safety and tolerance of TPCS 2a (tetraphenyl chlorin disulphonic acid,
Amphinex®) in bleomycin PCI, pharmacokinetic profiles, and determined the
maximum tolerated dose (MTD).
Method: Cohorts of 3 to 6 patients were enrolled and the TPCS2a dose escalated by a
pre-specified amount until dose-limiting toxicity (DLT) occurred in at least two
patients (≥33%). Patients received TPCS2a at a starting dose of 0.25mg/kg. Four days
later they received bleomycin (15,000IU/m 2 IV) and after 3 hours red light laser
(652nm) was applied to target lesions for 600 seconds to initiate a therapeutic
response. Patients were followed for 3 months.
Results: Nineteen patients were enrolled: 4 with cutaneous breast cancer, 13
squamous cell carcinoma (SCC) of head and neck and other regions, 2 other cancers.
17/19 patients experienced 94 AEs, most commonly pain, photosensitivity and
nausea. Most (83%) were mild or moderate. Fourteen episodes of pain (3 severe)
were treatment-related. Mean patient-reported pain using a VAS scale declined from
4.9 to 1.3 24 hours after treatment. Four patients experienced skin photosensitivity
reactions; 3 were in the highest dose cohort. 10/19 patients experienced 15 serious
adverse events: 3 (swelling, and blistering of hands, tongue oedema) were probably
related to treatment. The MTD of TPCS 2a was found to be 1.5mg/kg. At day 28, 11/
16 patients had a complete response (CR) in target lesions, 2 had a partial response
(PR), 2 had stable disease (SD) and 1 had progressive disease (PD). At last visit there
were 8 CRs, 2 PRs, 2 SDs and 2 PDs. During the course of the study four patients
died (no relation to treatment) and six were withdrawn prematurely.
Conclusion: With appropriate analgesia and anaesthesia TPCS 2a-based PCI of
bleomycin was well tolerated in these patients with locally advanced cancer.
Treatment-related AEs were as expected and can be managed. Preliminary
efficacy data are very encouraging and a phase II study in HNSCC has just
begun.
Disclosure: All authors have declared no conflicts of interest.
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds402 | ix347