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Blood, Vol. 94 No. 10 (November 15), 1999:
pp. 3289-3293
Treatment and Clinical Management of Primary Mediastinal Large B-Cell
Lymphoma With Sclerosis: MACOP-B Regimen and Mediastinal Radiotherapy
Monitored by 67Gallium Scan in 50 Patients
By
Pier Luigi Zinzani,
Maurizio Martelli,
Massimo Magagnoli,
Edoardo Pescarmona,
Laura Scaramucci,
Francesca Palombi,
Maurizio Bendandi,
Maria Paola Martelli,
Stefano Ascani,
Giulio Fraternali Orcioni,
Stefano A. Pileri,
Franco Mandelli, and
Sante Tura
From the Institute of Hematology and Medical Oncology
"Seràgnoli," University of Bologna, Bologna, Italy;
Department of Cellular Biotechnology and Hematology, University "La
Sapienza," Rome, Italy; Department of Experimental Medicine and
Pathology, University "La Sapienza," Rome, Italy; and Service of
Pathologic Anatomy and Unit of Hematopathology, University of Bologna,
Bologna, Italy.
 |
ABSTRACT |
To evaluate the efficacy of a combined modality treatment (MACOP-B
plus mediastinal radiotherapy) and the advantages of Gallium-67-citrate single-photon emission (67GaSPECT) over computed
tomography (CT) for restaging in patients with primary mediastinal
large B-cell lymphoma (PMLBCL) with sclerosis. Between 1989 and 1998, 50 previously untreated patients with PMLBCL with sclerosis (70% with
bulky mass) were treated with MACOP-B regimen plus mediastinal
radiotherapy. The radiologic clinical stage with evaluation of tumor
size included CT and 67GaSPECT at diagnosis, after
chemotherapy, and after radiotherapy. Forty-three patients (86%)
achieved a complete response and 7 were nonresponders to treatment. For
the imaging evaluation, only 47 patients were evaluable because 3 had
disease progression during chemotherapy. After treatment, 3/5 (60%)
patients with positive 67GaSPECT and negative CT scan
relapsed, as against 0/21 (0%) with negative 67GaSPECT and
CT scan. Twenty-one patients had a positive CT scan: of these, the 4 with positive 67GaSPECT all progressed, whereas there were
no relapses among the 17 with negative 67GaSPECT. After
radiotherapy, there was a decrease of positive CT (from 33 to 21 cases)
and of positive 67GaSPECT (from 31 to 9 cases).
Relapse-free survival rate was 93% at 96 months (median 39 months). In
patients with PMLBCL with sclerosis, MACOP-B plus radiation therapy is
a very useful first-line treatment and radiation therapy may play an
important role. As regards restaging, 67GaSPECT should be
considered the imaging technique of choice at least in patients who
show CT positivity.
© 1999 by The American Society of Hematology.
| |
INTRODUCTION |
PRIMARY MEDIASTINAL large B-cell lymphoma
(PMLBCL) with sclerosis is now considered to be a particular
clinical and pathological entity and has been included in the R.E.A.L.
classification1 among the aggressive non-Hodgkin's
lymphomas. It has a characteristic morphologic and immunophenotypic
picture2-5 showing a diffuse proliferation of large cells
with clear cytoplasm and the presence of variable degrees of sclerosis
that causes its typical compartmentalization pattern. PMLBCL with
sclerosis also presents with characteristic clinical features that are
almost specific, and with predominant or exclusive mediastinal
involvement. Women outnumber men by two to one, and the median age is
less than 30 years. The patients show a bulky mediastinal mass often
invading adjacent organs and structures (lung, superior vena cava,
pleura, pericardium, and the chest wall) producing typical symptoms of
cough, chest pain, and dyspnea.6-9 Bulky mediastinal
disease is observed in more than 60% to 70% of the patients and
intrathoracic extension to adjacent organs is present in about 50% of
patients. Only 20% of the patients are in stage III-IV at diagnosis
and extranodal spread or bone marrow involvement are rare. PMLBCL with
sclerosis can at times present with superior venacaval compression or
obstruction and, for this reason, requires rapid completion of
diagnosis and staging.
Several early reports10-12 described PMLBCL with sclerosis
as an aggressive disease with a poor prognosis when the patients were
treated with the Cyclophosphamide, Adriamycin, Vincristine, and
Prednisone (CHOP) regimen followed by radiation therapy,
whereas others13-16 reported good results using
first-generation chemotherapy regimens such as CHOP or CHOP-like. Other
reports17-21 have also described good results using other
third-generation Methotrexate, Adiramycin, Cyclophosphamide,
Vincristine, Prednisone, and Bleomycin (MACOP-B) or
MACOP-B-like regimens and radiotherapy. The use of high-dose therapy
and autologous stem cell transplantation in first remission has been
recommended in some reports22-23 but remains unproven. In
this study, we report the clinical findings and response to MACOP-B
chemotherapy regimen and mediastinal radiotherapy in 50 consecutive
patients with PMLBCL with sclerosis enrolled in a prospective trial who
underwent computed tomography (CT) and Gallium-67-citrate single-photon
emission (67GaSPECT) for routine restaging during and after treatment.
| |
MATERIALS AND METHODS |
Between 1989 and 1998 in our Institute and in Department of Hematology,
"La Sapienza" University (Rome, Italy), 50 consecutive patients
with PMLBCL with sclerosis completed treatment with MACOP-B regimen and mediastinal radiotherapy. Criteria for entry into the study
included: histologic diagnosis of PMLBCL with sclerosis according to
the R.E.A.L. classification1; stage I with bulky disease
and stages II-IV as outlined by the Ann Arbor conference24; no prior therapy. Radiological clinical staging with evaluation of
tumor size included total body CT and 67GaSPECT. CT was
monitored at diagnosis (before therapy), at the end of chemotherapy,
and 3 months after radiotherapy. 67GaSPECT was monitored at
the time of diagnosis and at the end of chemotherapy and 3 months after
radiotherapy (if conducted earlier 67GaSPECT can provide
false positives and, therefore, mislead even experienced
clinicians).25 The remaining staging procedures included
bone marrow biopsy and hematologic and biochemical survey. The extent
of mediastinal disease was defined by a mediastinal mass ratio (MMR),
calculated by measuring the maximum intrathoracic diameter; MMR that
exceeded one third or a mass measuring  10 cm in its largest single
diameter, as measured by CT, was considered as bulky.
Patients' characteristics.
Patients' characteristics are shown in
Table 1. The median age was 31 years
(range, 21 to 55 years); 30 (60%) were females and 20 (40%) males.
Forty-two (84%) had stage I-II and 8 (16%) stage III-IV disease. One
patient had bone marrow involvement. Systemic B symptoms were present
in only 14 (28%) patients. At diagnosis, 17 (34%) patients had
clinical features of superior vena cava syndrome whereas 17 (34%) had
pleural and 8 (16%) pericardial effusions, respectively. The
mediastinal involvement was bulky at presentation in 35 (70%)
patients.
Treatment protocol.
All patients were treated with the MACOP-B regimen as previously
described by Klimo et al.26 After 4 to 6 weeks from the completion of the chemotherapy program, all patients received radiation
therapy to the mediastinum with a tumor dose ranging from 30 to 36 Gy
over 4 to 5 weeks on a schedule of 180 cGy/day for 5 days per week; a
6-MV linear accelerator was used. Approval was obtained from the
Institutional Review Board for these studies. Informed consent was
provided according to the Declaration of Helsinki.
Evaluation of response.
Complete response was defined as a complete regression of all
assessable disease or a response 80% of residual mediastinal mass in
the size of clinically apparent disease without any evidence of
regrowth on completion of induction therapy. The mediastinal mass was
always measured in terms of product of the largest two perpendicular
diameters. For the purpose of this study, results of
67GaSPECT were not considered when assigning response
status after therapy. All patients had positive 67GaSPECT
at the time of diagnosis and at least one documented
67GaSPECT after the completion of combination therapy.
Partial response was defined as the reduction of at least 50% of known
disease with disappearance of the systemic manifestations. No response was defined as less than 50% reduction of the measurable tumor or
progression of the disease. Survival was calculated from the beginning
of treatment until death or last follow-up. Relapse-free survival was
estimated from the date of documented complete remission (CR) to the
last follow-up or relapse. The overall survival and relapse-free
survival curves were calculated using the Kaplan-Meier method.27
| |
RESULTS |
Three out of 50 (6%) patients showed a disease progression during
MACOP-B regimen and, for this reason, these patients were not included
on the imaging evaluation with both CT and 67GaSPECT.
The imaging outcome, which provided two possible situations, is
summarized in Table 2. Regarding CT scan,
33 of 47 (70%) patients had residual mediastinal tumor masses ( 20%
of the initial volume) after MACOP-B, and after radiation therapy 21 of
47 (44%) patients presented residual masses at CT. Regarding
67GaSPECT, 31/47 (66%) patients showed persistent abnormal
uptake after MACOP-B while following radiotherapy setting, only 9 of 47 (19%) patients were still 67GaSPECT positive. At the end
of treatment (see Table 3), 38 of 47 patients (81%) were gallium negative and none of these patients relapsed. Nine patients (19%) had persistent gallium-positive disease
in the mediastinum; in 5, the CT suggested CR but 3 of these 5 relapsed; in 4, CT scan was also abnormal and all 4 patients had
progressive disease. Therefore, our data argue strongly that gallium-scan negativity is an important prognostic factor in restaging patients treated for PMLBCL. It is noteworthy that after radiotherapy, 12 of 33 (36.5%) patients who had a CT residual mediastinal tumor after chemotherapy showed a negative CT. In addition, 22 of 31 (71%)
patients with positive 67GaSPECT after MACOP-B obtained a
negative 67GaSPECT after radiotherapy.
At the time of this analysis, 40 of 43 (93%) CR patients remain in
continuous CR with a median follow-up of 39 months (range 7 to 99 months). Three relapses were observed at 7, 8, and 10 months,
respectively: the first (mediastinum and lung relapse) subsequently
died after 25 months because of disease progression; the second
(mediastinum and kidney relapse) died after 8 months because of disease
progression in spite of two courses of the Ifosfamide, Epirubicin, and
Etoposide (IEV) regimen28 and autologous peripheral stem cell transplantation; the third (mediastinum and breast
relapse) achieved a second continuous CR after five courses of the IEV
regimen.28 All these 3 patients were CT negative but
67GaSPECT positive after the combined first-line treatment.
The other 2 patients with the same imaging situation after MACOP-B and
radiation therapy are still in continuous CR after 24 and 42 months. No
relapses were recorded in any of the other patients who had negative
67GaSPECT, independently of CT. As shown in
Fig 1, the overall survival was 82% at 96 months. The relapse-free survival curve of the 43 patients who achieved
CR showed a plateau at 93% (Fig 2) at 96 months.
| |
DISCUSSION |
The pathological and clinical characteristics of PMLBCL with sclerosis
have been well documented.1-5 The urgency of the initial presentation and its locally aggressive and invasive course justify the
idea that this lymphoma should prompt a rapid conclusion of diagnosis
and staging procedures. Response to treatment and clinical outcome have
varied from one series to another, probably owing to the small number
of patients in most series and the heterogeneity of treatment. Early
studies suggesting that PMLBCL with sclerosis were unusually aggressive
with a poorer prognosis with respect to other large-cell
lymphomas10-12 have been contradicted by more recent
reports. CR rates of 53% to 80% have been reported after initial
therapy with a 50% to 65% overall survival rate at 5 years.13-21 Regarding the use of different chemotherapeutic
regimens (CHOP or CHOP-like v third-generation regimens), a
recent report by Fisher et al29 showed that results with
CHOP are equivalent to results with intensive third-generation
regimens, and this may moderate calls for the use of more-aggressive
protocols in PMLBCL with sclerosis. Nevertheless, the debate is still
open because comparison of the advantages of the two different regimens is difficult, and, there is also the problem of explaining the different CR and survival rates reported from different institutions that use similar treatments, most likely due to patient selection. In
addition, the issue of adjuvant radiotherapy after chemotherapy also
remains open, although it seems likely that it could play an important
role in this locally aggressive disease, particularly in the presence
of bulky presentation.
The management of PMLBCL with sclerosis can be complicated by the
presence of residual masses of uncertain significance. Few clinical
tools are available to help identify patients in apparent CR or partial
remission (PR) who have occult residual disease. Incomplete regression
of a lymphomatous mass despite apparently effective therapy constitutes
a major problem in the treatment of this lymphoma, especially in
patients presenting with a bulky mediastinum. In many cases, such
residual masses consist of residual fibrotic tissue with no active
lymphomatous component, whereas in other cases active residual disease
may still be present. This dilemma can occur after combined modality
treatment (chemotherapy and radiation therapy). Recently, some
reports21,25,30-32 have stressed the potential usefulness
of 67GaSPECT scanning to discriminate between active
residual tumor and benign fibrous tissue.
To our knowledge the present study is the largest currently available
focusing on the real role of first-line MACOP-B regimen in combination
with radiation therapy and on the real efficacy of
67GaSPECT scanning in the qualitative evaluation of
residual mediastinal masses detected by CT in patients with PMLBCL with
sclerosis. In our study of 50 consecutive patients the MACOP-B regimen
plus mediastinal radiotherapy yielded a CR rate of 86% with only 7 nonresponders and a relapse-free survival of 93% at a median follow-up of 39 months. In the context of this combined therapeutic approach, radiation therapy turned out to be an important adjuvant treatment. Indeed, after its administration there was a decrease of positive CT
from 33 to 21 cases and of positive 67GaSPECT from 31 to 9 cases. As expected, CT showed a considerable percentage of residual
masses in the mediastinum after MACOP-B and radiation therapy, with a
persistent mass constituting 20% of the initial disease being
present in 45% of our patients.
All four CT+, 67GaSPECT+ patients
evidenced disease progression in the 67GaSPECT+
sites. This figure strongly contrasts with complete absence of relapses
among the 17 CT+, 67GaSPECT
patients. Moreover, it is noteworthy that 3/5 (60%)
CT patients who turned out to be
67GaSPECT+ relapsed within 10 months in
mediastinal sites in which disease had been present at diagnosis.
Finally, further evidence that 67GaSPECT+
restaging shows induction failure was supplied by the rapidity with
which the positive cases relapsed: 7/9 (78%)
67GaSPECT+ patients developed clinical disease
within 12 months of completing the combined modality treatment.
These findings lead us to conclude that a sequential weekly treatment
of a protocol such as MACOP-B, because of its continuous antineoplastic
effect over 3 months, may be considered a very useful first-line
therapeutic approach for PMLBCL with sclerosis. Secondly, this study
may provide a confirmation of 67GaSPECT's utility as a
specific tool for discriminating fibrotic and tumor tissue and
therefore its validity in the restaging of mediastinal masses in these
lymphomas after combined modality therapy. This restaging technique
allows identification of a subset of patients with residual
radiographic abnormalities who need no further therapy (negative
67GaSPECT) and of poor prognosis patients who do
require further treatment (ie, autologous bone marrow transplantation).
Thirdly, radiation therapy may have a pivotal role in this combined
modality of treatment. However, given the young age of the patient it
is not possible to ascertain whether radiation therapy is required for
the patients who became gallium-scan negative with chemotherapy. Further studies are needed to assess the possibility of using 67GaSPECT to select those patients who really require the
addition of radiation therapy after chemotherapy.
| |
FOOTNOTES |
Submitted May 21, 1999; accepted July 7, 1999.
The publication costs of this
article were defrayed in part by
page charge payment. This article
must therefore be hereby marked
"advertisement"
in accordance with 18 U.S.C. section
1734 solely to indicate this fact.
Address reprint requests to Pier Luigi Zinzani, MD, Istituto di
Ematologia e Oncologia Medica "Seràgnoli" Policlinico S. Orsola, Via Massarenti 9, 40138 Bologna, Italy.
| |
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TOP
ABSTRACT
INTRODUCTION
