There are several unresolved problems in the treatment of low grade gastric lymphoma, страница 2

Tumours which fail to respond to chlorambucil, or which transform to a high grade tumour, can be treated with CHOP chemotherapy.

Non-resected, partially or completely resected low grade gastric lymphoma, stage 1. Patients with CT scan evidence of pathologically enlarged abdominal lymph nodes are ineligible. Patients are not excluded by gastroscopic ultrasound evidence of enlarged nodes if the CT scan is normal.

Age 16 or over. Informed consent. Diagnostic material

In the UK 6 unstained slides should be sent to British National Lymphoma Investigation (BNLI), Department of Oncology, Middlesex Hospital, London WIN 8AA, for central review. Tel: 071 631 4787            Fax: 071 380 9427

Investigations prior to entry

1.   History and physical examination.

2.   Full blood count and differential white count. ESR.

3.    Biochemistry profile, including LDH and Pz microglobulin if possible.

4.   Chest X-ray.

5.   CT scan of chest, abdomen and pelvis.

6.   Bone marrow aspirate and biopsy.

7.   Diagnosis of H. pylori infection. This is normally made histologically but local practice may vary.

8. H. pylori serology if possible [we should like to collect a bank of sera at diagnosis and relapse. Please send 5ml of serum to British National Lymphoma Investigation (BNLI), Department of Oncology, Middlesex Hospital, Mortimer Street, London WIN 8AA

Registration and randomisation

All patients are registered at diagnosis.

The registration document should be completed and forwarded to the BNLI office.

Complete responders are randomised. Once randomised the patient remains in the study, whether treatment has to be changed or not.

Non-resected, partially or completely resected low grade gastric lymphoma, stage 1. Patients with CT scan evidence of pathologically enlarged abdominal lymph nodes are ineligible. Patients are not excluded by gastroscopic ultrasound evidence of enlarged nodes if the CT scan is normal.

Age 16 or over. Informed consent. Diagnostic material

In the UK 6 unstained slides should be sent to British National Lymphoma Investigation (BNLI), Department of Oncology, Middlesex Hospital, London WIN 8AA, for central review. Tel: 071 631 4787            Fax: 071 380 9427

Investigations prior to entry

1.   History and physical examination.

2.   Full blood count and differential white count. ESR.

3.    Biochemistry profile, including LDH and Pz microglobulin if possible.

4.   Chest X-ray.

5.   CT scan of chest, abdomen and pelvis.

6.   Bone marrow aspirate and biopsy.

7.   Diagnosis of H. pylori infection. This is normally made histologically but local practice may vary.

8. H. pylori serology if possible [we should like to collect a bank of sera at diagnosis and relapse. Please send 5ml of serum to British National Lymphoma Investigation (BNLI), Department of Oncology, Middlesex Hospital, Mortimer Street, London WIN 8AA

Registration and randomisation

All patients are registered at diagnosis.

The registration document should be completed and forwarded to the BNLI office.

Complete responders are randomised. Once randomised the patient remains in the study, whether treatment has to be changed or not.

Patients randomised to chlorambucil will receive chlorambucil 6mg/m2 daily po for 14 days repeated every 28 days for 6 cycles.

Treatment of partial and non-responders

Patients who fail to respond completely after eradication of H. pylori can still be randomised to observation or chlorambucil if the physician feels it is appropriate to do so, since there is evidence that stable and partially responding disease may not show progression over a long period. Nevertheless many clinicians will wish to treat these patients with cytotoxic therapy and we recommend chlorambucil.

Follow up investigation

,1 History and physical examination. ,2 FBC, ESR.

.3 Biochemistry, including LDH and pz microglobulinwhere possible.

.4 Serum sample for H. pylori serology to British National Lymphoma Investigation (BNLI), Department of Oncology, Middlesex Hospital, Mortimer Street, London WIN 8AA.

.5 Endoscopy at 6 month intervals for the first 2 years, thereafter at  yearly intervals, or if there is a recurrence of symptoms. We recommend at least 5 biopsies from various sites in the gastric mucosa as in 10.1 and 10.2.

Note: Endoscopic biopsy material must also be reviewed centrally. 6 unstained slides should be sent to the BNLI central office, at Department of Oncology, Middlesex Hospital, Mortimer Street, London WIN 8AA.

;. Treatment on relapse (or progression)