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Nuyttens et al. Cancer 2000

EORTC 62991-22998: Phase II pilot study of moderate dose radiotherapy for inoperable desmoid-type fibromatosis.

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Nuyttens et al. Cancer 2000

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  1. EORTC 62991-22998:Phase II pilot study of moderate dose radiotherapy for inoperable desmoid-type fibromatosis Ronald B. Keus, Remi A. Nout, Jean-Yves Blay, Joseph M. de Jong, Frank Saran, Michael Sokal, Joerg T. Hartmann, Steve J. Gwyther, Pancras C. Hogendoorn, Monia Ouali, Anne Kirkpatrick, Wilfried Budach, Winette van der Graaf.

  2. Nuyttens et al. Cancer 2000

  3. Nuyttens et al. Cancer 2000

  4. Study Objectives and Design • Single arm phase II trial to determine the efficacy of moderate doses of radiotherapy for desmoid-type fibromatosis in patients with inoperable tumor or when mutilating surgery is needed. • Radiation schedule tested • 56 Gy in 28 fractions 2 Gy per fraction 5 fractions per week • Primary objective: demonstrate that local control rate at 3 years> 50% • Sample size: To exclude a 3-year local-control rate ≤50% with 1-sided =10% and 90% power if the true local-control rate is 70%  40 patients needed (Fleming design)

  5. Study population • Histologically confirmed desmoid-type fibromatosis arising in any site in one of the following categories: • Primary, recurrent (after prior complete remission or complete resection) or progressive (after any prior treatment not including radiotherapy) disease, that is either inoperable, or requiring a major operation resulting in a large functional or cosmetic deficit or mutilation (confirmed by a surgeon) • Incompletely resected tumor leaving gross residual disease not suitable for further surgery. (Surgery performed <3 m before entry) • Measurable disease according to RECIST 1.0 • No concurrent endocrine or chemotherapy • No prior or concurrent limb perfusion with TNF • Age ≥ 16 years • Informed consent

  6. Accrual 44 patients recruited between 13/11/ 2001 and 02/04/2008

  7. Eligibility and analysis populations Median follow-up:4.8 years

  8. Patient characteristics

  9. Disease characteristics

  10. Prior treatments

  11. Irradiation technique

  12. Radiation therapy 4 patients interrupted irradiation: 3 for toxicity (epidermitis G3, erythema G2, skin blistering) and 1 due to an unrelated medical event.

  13. Acute side efffects (CTC – AE 2.0)

  14. Late toxicity (RTOG-EORTC)

  15. Local control at 3 years: main analysis 100 81.5% 90 80 70 80% CI: 74.0%-89.1% 60 50 95% CI: 71.8%-91.3% 40 30 This is >50%  Success! 20 10 Time (years) .0 1 2 4 6 8 10 3

  16. Objective response to therapy Objective response to therapy was evaluated on the basis of lesions included in the irradiation field. After 3 years the response further improved in 3 patients: PR => CR 1, SD =>CR 1 and SD => PR 1 patient . Five patients had new lesions, 1 was located in the RT fields.

  17. Conclusions • Moderate dose of radiotherapy is an effective treatment for patients with desmoid-type fibromatosis resulting in 81.5% local control rate at 3 years. • Response after radiation therapy is slow with continuous regression even after 3 yrs. • Acute side effects are mild. Edema as late toxicity in patients with extremity lesions was seen frequently. • Radiotherapy should be considered for patients with symptomatic and progressive desmoid-type fibromatosis.

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