Extended Field Irradiation and Intracavitary Brachytherapy Combined With Cisplatin Chemotherapy for

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Extended Field Irradiation and Intracavitary
Brachytherapy Combined With Cisplatin
Chemotherapy for Cervical Cancer With Positive
Para-aortic or High Common Iliac Lymph Nodes
Results of Arm 1 of RTOG 0116

• W. Small Jr., K. Winter, C. Levenback, R. Iyer,
  D. Gaffney, S. Asbell, B. Erickson, K. Greven.

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Background

• Combined Chemotherapy and Radiation has become
  the standard treatment for advanced cervical
  cancer confined to the pelvis.
• Patients with lymph node metastasis to the
  para-aortic lymph nodes are curable with extended
  field radiotherapy and brachytherapy.
• There is a suggestion in the literature that the
  addition of chemotherapy to radiation improves
  control rates although with increased toxicity.

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Study Design

• RTOG 0116 was designed as a two part trial Arm 1
  delivered extended field radiotherapy weekly
  cisplatin brachytherapy. Arm two delivers an
  identical regimen with the addition of daily
  Amifostine.

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Primary Objectives

• Arm 1 To determine tolerance levels of
  extended-field and intracavitary irradiation with
  weekly cisplatin
• Arm 2 To determine if the addition of Amifostine
  reduces grade 34 acute toxicity, excluding grade
  3 leukopenia.
• The primary objective of arm 1 will be presented.

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Secondary Objectives

• Determine feasibility of each part of this study.
  
• Evaluate efficacy of extended-field and
  intracavitary irradiation with weekly cisplatin
  /- Amifostine with respect to pelvic and
  para-aortic tumor control.
• Evaluate efficacy of extended-field and
  intracavitary irradiation with weekly cisplatin
  /- Amifostine with respect to distant
  metastasis.

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Eligibility

• Squamous, adenosquamous or adenocarcinoma of the
  cervix.
• Evidence for high common iliac and/or para-aortic
  metastasis.
• Standard performance status, hematologic/chemistry
  eligibility.

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Treatment

• 45 Gy in 1.8 Gy/fraction extended field
  radiotherapy to an upper border of T11/12.
• Weekly cisplatin at 40 mg/m2 for the 5 weeks of
  external beam radiotherapy and with one
  brachytherapy fraction (total of six doses of
  cisplatin).
• LDR or HDR brachytherapy to an LDR equivalent
  dose of 85 Gy to point A, lateral parametrium or
  positive pelvic nodes to 60 Gy /- 5.
• Optional boost to non-pelvic lymph nodes to a
  total dose of 54 59.6 Gy.

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Results

• RTOG 0116 was opened on August 1, 2001 and
  completed accrual to arm one on December 3, 2003.
• A total of 27 patients were entered on Arm 1.
• One patient was deemed ineligible due to an
  endometrial primary and the results are based on
  the 26 eligible patients.
• Acute toxicity was scored with CTC Version 2.0
  and late RT toxicity with the RTOG/EORTC late RT
  morbidity scoring scheme.

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Nodal Involvementat Study Entry
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Follow-up
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Acute Toxicity Summary
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Acute Non-Hematologic Grade 3 and 4 Toxicity
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Late Grade 34 Toxicity
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Late GI Toxicity

• 6 patients (23) underwent surgery for a GI
  complication.
• 5 of these patients have been left with a
  colostomy.

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Complete Response Following Treatment
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Absolute Survival RTCisplatin
Dead/Total 13/26
Survival ()
Months from Randomization
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Disease-Free Survival RTCisplatin
Failed/Total 17/26
Disease-Free Survival ()
Months from Randomization
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Conclusions

• Extended field radiotherapy with concurrent
  cisplatin as delivered in this trial was
  associated with high rates of acute and late
  toxicity.
• Disease free Survival at 18 months was 42.
• The study is currently accruing patients to the
  Amifostine arm.

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Thank you