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BIO Magazine - DESKTOP III Δεκέμβριος 2015
Δεκέμβριος 2015 No38

BIO Health

DESKTOP III
DESKTOP III

The cornerstones of ovarian cancer management are surgery and chemotherapy. The goal of surgery is removal of all gross tumour deposits (complete cytoreduction). Over the past decade there has been little improvement in the cure rate of ovarian cancer. During this time the combination of carboplatin and paclitaxel has remained as the standard first-line therapy. Response rates to this combination are in the region of 70%–80%, but the majority of these women subsequently relapse . The DESKTOP I trial identified an independently predictive score for complete resection (AGO score) comprehensive of good performance status (Eastern Cooperative Oncology Group 0), complete resection at primary surgery (or alternatively, International Federation of Gynecology and Obstetrics stage I/II), and the absence of ascites. If all the 3 factors were contemporarily present (positive AGO score), complete resection was feasible in 79% of patients. The subsequent international multicenter trial DESKTOP II prospectively validated this score: 129 patients with positive AGO score submitted to secondary surgery for ovarian cancer recurrence were enrolled with a confirmed complete resection rate of 76%.

DESKTOP III is a randomized trial evaluating cytoreductive surgery in patients with platinum-sensitive recurrent ovarian cancer.

 

Primary Outcome Measures:

  1. Overall survival in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score

Secondary Outcome Measures:

  1. Quality of Life
  2. Progression free survival

Main inclusion criteria: 

  1. Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage.
  2. Progression-free interval of at least 6 months after end of last platinum-containing therapy.
  3. Or Recurrence within 6 months or later after primary surgery if the patient has not received prior chemotherapy in patients with FIGO I. Non cytostatic maintenance therapy not containing platinum will not be considered for this calculation.
  4. A positive AGO-score. Obligatory requirements for a positive AGO recurrence score in platinum-sensitive disease.
  5. Performance status ECOG 0.
  6. No residual tumour after primary surgery (if unknown, alternatively primary FIGO stage I/II). If report from 1st surgery is not available contact study chairman who may decide whether the patient could be included.
  7. Absence of ascites (cut off < 500 ml: radiological or ultrasound estimation).
  8. Women aged ≥ 18 years.
  9. Complete resection of the tumour by median laparotomy seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by MRI/CT, if other surgical approaches for isolated extra-abdominal recurrences are planned.
  10. Written informed consent for study participation.
  11. Patients who have given their signed and written informed consent to data transmission and processing.

 

 

Main exclusion criteria:

  1. Patients with non-epithelial tumours as well as borderline tumours.
  2. Patients without recurrence but who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy.
  3. More than one prior chemotherapy.
  4. Patients with second, third, or later recurrence.
  5. Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
  6. Patients with so-called platinum-refractory tumour i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum containing therapy.
  7. Only palliative surgery planned.
  8. Metastases not accessible to surgical removal.
  9. Any concomitant disease not allowing surgery and/or chemotherapy.

 

References

  1. International Collaboration for Ovarian Neoplasia Group. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet 2003;361:2099-2106.
  2. R. A. Segna, P. R. Dottino, J. P. Mandeli, K. Konsker, and C. J. Cohen, “Secondary cytoreduction for ovarian cancer following cisplatin therapy,” Journal of Clinical Oncology, vol. 11, no. 3, pp. 434–439, 1993
  3. L. Vaccarello, S. C. Rubin, V. Vlamis et al., “Cytoreductive surgery in ovarian carcinoma patients with a documented previously complete surgical response,” Gynecologic Oncology, vol. 57, no. 1, pp. 61–65, 1995.
  4. P. Harter, A. D. Bois, M. Hahmann et al., “Surgery in recurrent ovarian cancer: The Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) DESKTOP OVAR trial,” Annals of Surgical Oncology, vol. 13, no. 12, pp. 1702–1710, 2006.
  5. . M. Lenhard, A. Burges, T. R. C. Johnson et al., “Predictive value of PET-CT imaging versus AGO-scoring in patients planned for cytoreductive surgery in recurrent ovarian cancer,” European Journal of Obstetrics Gynecology and Reproductive Biology, vol. 140, no. 2, pp. 263–268, 2008.
  6. R. E. Bristow, I. Puri, and D. S. Chi, “Cytoreductive surgery for recurrent ovarian cancer: a meta-analysis,” Gynecologic Oncology, vol. 112, no. 1, pp. 265–274, 2009.

Christos Iavazzo MD, MSc, PhD

Senior Clinical Fellow Gynaecological Oncology Department, Royal Surrey County Hospital, Guildford, United Kingdom

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