A prospective study of dosereduction threecourse CHOP followed by involvedfield radiotherapy for eld

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A prospective study of dose-reduction
three-course CHOP followed by involved-field
radiotherapy for elderly patients 70 years old or
more with localized aggressive non-Hodgkins
lymphoma
2331

• Japan Radiation Oncology Group (JAROG)
• Naoto Shikama, Masahiko Oguchi,
• Yoshikazu Kagami, Kouichi Isobe,
• Katsumasa Nakamura, Yoshio Tamaki,
• Masatoshi Hasegawa, Shigeru Sasaki

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Background

• Standard care for elderly patients over 70 years
  old with localized aggressive lymphoma has not
  been established.
• We conducted a multi-center prospective study to
  evaluate the efficacy and safety of
  dose-reduction three-course CHOP followed by
  involved-field radiotherapy (IFRT) for elderly
  patients with localized aggressive lymphoma.

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Purpose

• Primary endpoint
• Compliance with combined modalities
• Assumption of compliance 90
• Below limit of compliance 70
• Alpha error 0.05 Beta error 0.2
• Secondary endpoints
• Progression-free survival (PFS)
• Overall survival
• Toxicity

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Eligibility criteria

• Elderly patients (70 years)
• Diffuse aggressive lymphoma
• diffuse large B-cell
• peripheral T-cell
• anaplastic large cell lymphoma
• Stage I-IIA
• IA /- bulky tumor (10 cm)
• IIA contiguous non-bulky stage IIA
• PS 02
• LDH 1.5 upper limit of normal range
• Extra nodal sites 01
• Written informed consent

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Treatment (Chemotherapy Radiotherapy)

• Chemotherapy
• 80-dose CHOP 3 cycles
• Cyclophosphamide 600 mg/m2
• Doxorubicin 40 mg/m2
• Vincristine 1.1 mg/m2
• Prednisone 80 mg/day 5 days
• Radiotherapy
• Involved-field
• CR 30 Gy/20 fractions
• non-CR 4050 Gy/2028 fractions

CR Complete responder after chemotherapy
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Results24 patients (Dec 2000 Feb 2004)

• Age (Median 75 years)
• 7075 15 pts
• 7684 9
• PS (ECOG)
• 0 18 pts
• 1 6
• Stage
• IA 16 pts
• IIA 8
• LDH
• ULN 20 pts
• 1xlt, lt1.5ULN 4

• Location
• Waldeyers ring 11 pts
• Neck nodes 6
• Maxillary sinus 3
• Thyroid 2
• Parotid gland 1
• Paravertebral area 1
• Tumor size
• 6 cm 19 pts
• 6-10 cm 4
• 10 cm 1
• F/U (Median 38 mo.)

ULN Upper limit of the institutional normal
range, mo. months
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Results

• Compliance rate 87.5 (95CI, 67.697.3)
• Off protocol 3 pts
• 73 y.o. Male, PS 0, Stage IA, Neck nodes
• Interstitial pneumonia (Grade 3)
• 74 y.o. Male, PS 1, Stage IA, Waldeyers ring
• Neutropenia (Grade 3)
• 78 y.o. Male, PS 0, Stage IA, Nasopharynx
• Neutropenia (Grade 3), Diabetes Mellitus (Grade
  3)
• No treatment-related deaths
• 3-year PFS rate 83.1 (95CI, 75.490.8)

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Overall survival curve of all 24 patients

• 3-year overall survival rate 82.9
• (95CI, 75.190.6)

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Results
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Results
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Conclusions

• Combined modality therapy with three-course
  80-CHOP and IFRT can be administered safely for
  elderly patients over 70 years old.
• In future, the addition of Rituximab, which is a
  chimeric human/murine immunoglobulin G1?
  monoclonal antibody that binds specifically to
  the B-cell surface antigen, CD20, to this
  regimen should be evaluated for elderly patients
  with limited disease.