Intervention Protocol

Optimisation of chemotherapy and radiotherapy for untreated Hodgkin lymphoma patients with respect to second malignant neoplasms, overall and progression-free survival

  1. Jeremy Franklin1,*,
  2. Dennis Eichenauer2,
  3. Ina Monsef3,
  4. Andreas Engert3

Editorial Group: Cochrane Haematological Malignancies Group

Published Online: 10 NOV 2010

DOI: 10.1002/14651858.CD008814


How to Cite

Franklin J, Eichenauer D, Monsef I, Engert A. Optimisation of chemotherapy and radiotherapy for untreated Hodgkin lymphoma patients with respect to second malignant neoplasms, overall and progression-free survival (Protocol). Cochrane Database of Systematic Reviews 2010, Issue 11. Art. No.: CD008814. DOI: 10.1002/14651858.CD008814.

Author Information

  1. 1

    University Hospital of Cologne, Institute of Medical Statistics, Informatics and Epidemiology, Cologne, Germany

  2. 2

    University Hospital of Cologne, Department I of Internal Medicine, Center of Integrated Oncology Köln Bonn, Cologne, Germany

  3. 3

    University Hospital of Cologne, Cochrane Haematological Malignancies Group, Department I of Internal Medicine, Cologne, Germany

*Jeremy Franklin, Institute of Medical Statistics, Informatics and Epidemiology, University Hospital of Cologne, Kerpener Str. 62, Cologne, 50937, Germany. jeremy.franklin@uk-koeln.de.

Publication History

  1. Publication Status: New
  2. Published Online: 10 NOV 2010

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Abstract

  1. Top of page
  2. Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

The main objective is to assess and compare the risks of secondary malignant neoplasms, including secondary solid tumours, secondary NHL and secondary AML, in HL patients according to the design of first-line treatment, which includes use of chemotherapy, radiotherapy, or both, type and amount of chemotherapy and extent and dosage of radiation.

A list of study questions (SQ) follows. One SQ concerns the intensification of first-line therapy, while the remainder deal with de-intensification.

Two questions were adopted from the original systematic review (Franklin 2005).

  • SQ1. Does the avoidance of additional radiotherapy lessen the risk of secondary malignant neoplasms (separately for early and advanced stages)? The original review demonstrated lower risk for chemotherapy alone.
  • SQ2. Does the use of involved-field radiation lessen the risk of secondary malignant neoplasms compared with extended-field radiation (early stages)? The original review did not show a significant difference.

Three novel questions:

  • SQ3. does the use of reduced-dose radiation (e.g., 20 Gy or 30 Gy) reduce the risk of secondary malignant neoplasms compared with the standard (circa 35 to 40 Gy)?
  • SQ4: does the use of fewer chemotherapy cycles lessen the secondary malignant neoplasm risk?
  • SQ5: does the use of intensified chemotherapy regimens, which have been demonstrated to improve efficacy, increase the risk of secondary malignant neoplasms?

For all these SQs, secondary malignant neoplasm risk will be set in the context of differences in efficacy by evaluation of progression-free and overall survival. Furthermore, it is known that the various types of secondary malignant neoplasms, namely acute leukaemia, non-Hodgkin lymphoma and solid tumours, differ greatly in their respective risk factors, including treatment factors. Thus, these treatment comparisons will also be made separately with respect to each type.

Risks due to the first-line therapy alone and additional risks due to salvage treatment for progressing and relapsing patients will be investigated. Except as a means of assessing data quality, no attempt is made to estimate secondary malignant neoplasm risks relative to the general population.

Further, the overall and progression-free survival rates following these interventions will be compared. The results concerning secondary malignant neoplasms will be assessed in the light of this information. Conclusions will be drawn concerning the advantages and disadvantages of each treatment modality for relevant categories of patients.