CONCURRENT PACLITAXEL AND RADIOTHERAPY - TREATMENT FEASIBILITY STUDIES

Background: The anti-neoplastic effect of paclitaxel has been demonstr ated in various clinical studies in different malignant diseases. Clin ical studies have also demonstrated a greater efficacy for simultaneou s radio-chemotherapy compared with radiotherapy alone when using radio sensitizing drugs. Based on these clinical and in-vitro data we initia led several pilot studies using paclitaxel as a radiosensitizing agent and we now present our initial experience in its use in a combined mo rtality protocol, radiation and simultaneous chemotherapy with paclita xel. Methods: I, Concurrent paclitaxel and radiation for locally advan ced non-small-cell lung cancer (NSCLC): In a phase-I study we applicat ed paclitaxel (45 to 65 mg/m(2)) as a 3-hour infusion weekly for 3 to 7 weeks simultaneously with primary radiotherapy in shrinking field te chnique with 5 x 1.8 Gy/week up to 59.4 Gy. - II. Concurrent paclitaxe l and radiation for breast cancer as neoadjuvant or palliative: 50 mg/ m(2) paclitaxel as a 3-hour infusion weekly for 6 weeks simultaneous w ith neoadjuvant or palliative radiotherapy of the breast/chest wall wi th 5 x 1.8 Gy/week up to 54.0 Gy.-III./IV. Concurrent paclitaxel/carbo platin and combined radiation (EBRT + brachytherapy) for locally advan ced inoperable cancer of the cervix: 50 mg/m(2) paclitaxel as a 3-hour infusion weekly for 5 weeks, 50 mg/m(2) carboplatin at day 1 to 5 in week 1 and 5 simultaneously with external beam radiotherapy of the pel vis with 5 x 1.8 Gy/week up to 54.0 Gy and endocavitary LDR brachyther apy (4 x 5 Gy). - V. Concurrent paclitaxel and radiation for locally a dvanced inoperable cancer of the bladder: 50 mg/m(2) paclitaxel as a 3 -hour infusion weekly for 5 weeks simultaneous with radiotherapy of th e pelvis with 5 x 1.8 Gy/week up to 50.4 Gy. - VI, Concurrent paclitax el and radiation in locally advanced inoperable head and neck cancer: 50 mg/m(2) paclitaxel as a 3-hour infusion weekly for 7 to 8 weeks sim ultaneous with radiotherapy in shrinking field technique with 5 x 1.8 Gy/week up to 59.4 to 73.8 Gy. - VII. Concurrent paclitaxel and radiat ion for gliomas of the brain: 100 mg/m(2) paclitaxel as a 3-hour infus ion weekly for 6 weeks simultaneous with radiotherapy in shrinking fie ld technique with 5 x 2 Gy/week up to 60 Gy. Results: Our initial expe riences with weekly application of paclitaxel as a 3-hour infusion in the dosages we used for simultaneous radiochemotherapy of malignancies in different anatomical sites has shown that this treatment concept i s feasible, safe and effective. Conclusions: Whether this combined mod ality will enhance the response rates or influence survival rates has yet to be confirmed in phase-III studies.