Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin Lymphoma
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About
RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before, during, and after chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.
PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage III, or stage IV Hodgkin lymphoma.
Full description
OBJECTIVES:
- To determine if fludeoxyglucose F 18 (FDG)-PET/CT imaging can be reproducibly and effectively applied in the early assessment of response to chemotherapy in patients with newly diagnosed stage II-IV Hodgkin lymphoma.
- To determine if a negative FDG-PET/CT scan after 2 courses of ABVD chemotherapy comprising doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine can be used to predict a group of patients for whom it is safe to reduce therapy by the subsequent omission of bleomycin, without detriment to progression-free survival.
- To determine if treatment intensification in response to positive FDG-PET/CT imaging after 2 courses of ABVD chemotherapy can improve the outcome by comparison with previous series.
OUTLINE: This is a multicenter study.
Patients undergo fludeoxyglucose F 18 (FDG)-PET/CT imaging at baseline. Patients then receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy is based on FDG-PET/CT scan results.
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Negative FDG-PET/CT scan: Patients with a negative FDG-PET/CT scan are randomized to 1 of 2 treatment arms.
- Arm I (ABVD chemotherapy): Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (AVD chemotherapy): Patients receive AVD chemotherapy comprising doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
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Positive FDG-PET/CT scan: Patients with a positive FDG-PET/CT scan are assigned to 1 of 2 chemotherapy regimens, as determined by the participating center.
- BEACOPP-14 chemotherapy: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride and oral prednisolone on days 1-7; and bleomycin IV and vincristine IV on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 8-13 OR pegfilgrastim SC once on day 8. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- BEACOPP-escalated chemotherapy: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride on days 1-7; oral prednisolone on days 1-14; and bleomycin IV and vincristine IV on day 8. Patients also receive G-CSF SC beginning on day 8 and continuing until blood counts recover OR pegfilgrastim SC once on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of BEACOPP chemotherapy, patients undergo a third FDG-PET/CT scan to assess response. Patients with a negative FDG-PET/CT scan receive 2 more courses of BEACOPP-14 or 1 more course of BEACOPP-escalated chemotherapy. Patients with a persistently positive FDG-PET/CT scan may receive radiotherapy to sites of FDG uptake or salvage chemotherapy, at the investigator's discretion.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed classical Hodgkin lymphoma (HL) meeting the following criteria:
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Meets current WHO classification criteria (i.e., nodular sclerosis, mixed cellularity, lymphocyte rich, and lymphocyte-depleted)
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Clinical stage IIB, III, or IV disease OR clinical stage IIA disease with adverse features, including any of the following:
- Bulk mediastinal disease, defined as maximal transverse diameter of mass > 0.33 of the internal thoracic diameter at D5/6 interspace on routine chest x-ray
- Disease outside the mediastinum and lymph node or lymph node mass > 10 cm in diameter
- More than two sites of disease
- Other poor-risk features that require treatment with full course combination chemotherapy
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Newly diagnosed disease
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No CNS or meningeal involvement by lymphoma
PATIENT CHARACTERISTICS:
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ECOG performance status 0-3
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Life expectancy > 3 months
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ANC > 1,500/mm^3 (unless there is bone marrow infiltration by lymphoma)
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Platelet count > 100,000/mm^3 (unless there is bone marrow infiltration by lymphoma)
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Creatinine < 150% of upper limit of normal (ULN)
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Bilirubin < 2.0 times ULN (unless attributed to lymphoma)
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Transaminases < 2.5 times ULN (unless attributed to lymphoma)
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LVEF ≥ 50% (in patients with a significant history of ischemic heart disease or hypertension)
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Diffusion capacity within 25% of normal predicted value by lung function testing
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
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Amenable to the administration of a full course of chemotherapy, according to the investigator
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Must have access to PET/CT scanning
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No poorly controlled diabetes mellitus
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No cardiac contraindication to doxorubicin hydrochloride, including abnormal contractility by ECHO or MUGA
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No neurological contraindication to chemotherapy (e.g., pre-existing neuropathy)
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No other concurrent uncontrolled medical condition
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No other active malignant disease within the past 10 years, except fully excised basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
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No known positivity for HIV, hepatitis B surface antigen, or hepatitis C
- Routine testing, in the absence of risk factors, is not required
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No medical or psychiatric condition that compromises the patient's ability to give informed consent
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy or other investigational drug for HL
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,202 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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