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Radiotherapy versus Concurrent 5-Day Cisplatin and Radiotherapy in Locally Advanced Cervical Carcinoma

Long-Term Results of a Phase III Randomized Trial

Radiotherapie versus Radiochemotherapie mit Cisplatin für 5 Tage bei fortgeschrittenem Zervixkarzinom. Langzeitergebnisse einer randomisierten Phase-III-Studie

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Purpose:

To prove the superiority of concurrent radiochemotherapy (RTCT) over radiotherapy (RT) alone in locally advanced cervical carcinoma.

Patients and Methods:

In this randomized monocentric phase III study, 566 patients with squamous cell carcinoma of the cervix were included: 284 in arm A (RT) and 282 in arm B (concurrent RTCT with cisplatin 20 mg/m2 × 5 days). 238 patients (42%) were in stage IIB, 209 (37%) in stage IIIA, and 119 (21%) in stage IIIB. The median follow-up was 62.8 months. RT to the pelvis was delivered to a dose of 46 Gy/23 fractions. A cervical boost was given using the X-ray arch technique or high-dose-rate intracavitary brachytherapy at a dose of 10 Gy. Thereafter, patients were evaluated: those with good response optionally underwent surgery and the others continued RT until 64 Gy/pelvis (with or without CT according to randomization) and 14 Gy/central tumor volume.

Results:

The 5-year survival rate was statistically significantly superior in the concurrent RTCT group (74%) versus the RT group (64%; p < 0.05). In patients undergoing surgery after RT or RTCT, superior results were obtained, compared to the nonoperated patients: 5-year survival rate 86% versus 53% (p < 0.01). 192 failures were recorded: 109 (38%) after RT alone versus 83 (29%) after concurrent RTCT (p < 0.01).

Conclusion:

The results of this study prove the obvious superiority of concurrent RTCT with 5-day cisplatin compared to RT alone in patients with locally advanced cervical carcinoma, regarding local control (78% vs. 67%) and 5-year survival rates (74% vs. 64%).

Ziel:

Nachweis der Überlegenheit einer begleitenden Radiochemotherapie (RTCT) gegenüber alleiniger Radiotherapie (RT) beim lokal fortgeschrittenen Zervixkarzinom.

Patienten und Methodik:

566 Patientinnen mit Plattenepithelkarzinom der Zervix wurden eingeschlossen: 284 in Arm A (RT) und 282 in Arm B (RTCT, simultane CT mit Cisplatin 20 mg/m2 × 5 Tage). 238 Patientinnen (42%) waren im Stadium IIB, 209 (37%) im Stadium IIIA und 119 (21%) im Stadium IIIB. Der mediane Nachbeobachtungszeitraum betrug 62,8 Monate. Die perkutane RT wurde bis 46 Gy durchgeführt. Ein Zervixboost wurde mittels Brachytherapie oder perkutaner RT in Pendeltechnik mit 10 Gy appliziert. Anschließend wurden die Patientinnen neu beurteilt: Jene mit gutem Ansprechen wurden operiert und die anderen bis 64 Gy perkutan im Becken und zusätzlichen 14 Gy an der Zervix bestrahlt (mit/ohne CT je nach Randomisierung; Abbildung 1).

Ergebnisse:

Die 5-Jahres-Überlebensrate war in der simultanen RTCT-Gruppe statistisch signifikant besser (74%) als in der RT-Gruppe (64%; p < 0,05) (Abbildung 2). Bei Patientinnen mit gutem lokalen Ansprechen, welches eine Operation erlaubte, war die 5-Jahres-Überlebensrate im Vergleich zu den nichtoperierten Patientinnen statistisch signifikant besser: 86% versus 53% (p < 0,01; Abbildung 3). Die histologische Bewertung der Operationspräparate zeigte bei 64% der Patientinnen eine komplette Remission: in 71% (102/143) nach RTCT versus 56% (72/129) nach RT (p < 0,01; Tabellen 1 und 2). Bei histologisch vollständigem Ansprechen war die 5-Jahres-Überlebensrate signifikant höher als bei Nichtansprechen (Abbildung 4).

Schlussfolgerung:

Die Ergebnisse beweisen die Überlegenheit der RTCT mit Cisplatin gegenüber der alleinigen RT beim lokal fortgeschrittenen Zervixkarzinom.

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Authors and Affiliations

  1. Department of Radiation Oncology, “Ion Chiricuta” Cancer Institute, Cluj-Napoca, Romania

    Viorica Nagy, Ovidiu Coza, Claudia Ordeanu, Nicolae Todor & Nicolae Ghilezan

  2. “Iuliu Hatieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania

    Viorica Nagy, Ovidiu Coza, Alin Rancea & Nicolae Ghilezan

  3. Department of Surgery, “Ion Chiricuta” Cancer Institute, Cluj-Napoca, Romania

    Alexandru Třailă & Alin Rancea

  4. Department of Radiation Oncology, “Ion Chiricuta” Cancer Institute, Republicii Street 34–36, 400015, Cluj-Napoca, Romania

    Viorica Nagy

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  1. Viorica Nagy
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  2. Ovidiu Coza
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  7. Nicolae Ghilezan
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Correspondence to Viorica Nagy.

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Nagy, V., Coza, O., Ordeanu, C. et al. Radiotherapy versus Concurrent 5-Day Cisplatin and Radiotherapy in Locally Advanced Cervical Carcinoma. Strahlenther Onkol 185, 177–183 (2009). https://doi.org/10.1007/s00066-009-1893-z

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  • DOI: https://doi.org/10.1007/s00066-009-1893-z

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