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 Previous Article | Table of Contents | Next Article 
Blood, Vol. 93 No. 11 (June 1), 1999:
pp. 3632-3636
ASHAP: A Regimen for Cytoreduction of Refractory or Recurrent
Hodgkin's Disease
By
J. Rodriguez,
M.A. Rodriguez,
L. Fayad,
P. McLaughlin,
F. Swan,
A. Sarris,
J. Romaguera,
B. Andersson,
F. Cabanillas, and
F.B. Hagemeister
From the Department of Lymphoma and Myeloma, The University of Texas,
M.D. Anderson Cancer Center, Houston, Texas.
 |
ABSTRACT |
Patients with Hodgkin's disease, which is either refractory or
recurs after frontline chemotherapy with MOPP (mechlorethamine, vincristine, procarbazine, and prednisone), ABVD
(doxorubicin, bleomycin, vinblastine, and dacarbazine), or
both regimens, generally have a poor prognosis. High-dose chemotherapy
with autologous marrow or stem cell rescue (ABMT) is now a widely used
salvage strategy in these patients. In this study, our objective was to determine the response rate to ASHAP (Adriamycin = doxorubicin, Solumedrol = methylprednisolone, High-dose Ara-C = cytosine
arabinoside, and Platinum = cisplatinum), in a group of patients with
Hodgkin's disease with such poor risk characteristics. The treatment
was intended as a brief tumor reducing program before ABMT. Fifty-six patients with diagnosed relapsed or primary refractory Hodgkin's disease underwent this treatment. The program consisted of the administration of two cycles of ASHAP chemotherapy (doxorubicin 10 mg/m2/d intravenous (IV) continuous infusion (CI) over 24 hours, days 1 to 4; methylprednisolone 500 mg/d IV over 15 minutes
daily for 5 days; cisplatinum 25 mg/m2/d IV CI over 24 hours, days 1 to 4; cytosine arabinoside 1.5 g/m2/d IV over
2 hours on day 5). After two courses of ASHAP the patients were
evaluated for response, including a gallium scan test. Patients with
progressive disease were taken off the study. Those with responding or
stable disease received a third course of ASHAP, followed by
consolidative treatment with ABMT. There were 19 complete responses
(34% CR), 20 partial responses (36% PR), and 17 treatment failures,
including 8 with minor responses and 9 with disease progression. Thus,
in total there were 39 responses out of 56 patients (CR + PR
= 70%). Myelosuppression was the main toxicity. There were no
deaths due to toxicity. At this time, 23 patients are alive. There were
31 deaths due to disease progression and 2 due to other causes. The
initial response to ASHAP before subsequent ABMT consolidation
treatment correlated with survival. All 17 patients in whom ASHAP
failed to achieve a response have died. The presence of B symptoms at
relapse, and a duration of response to the last regimen of  6 months,
predicted a poor response to ASHAP. A short program of treatment
with ASHAP is an effective tumor debulking approach in patients
previously treated with both or either ABVD and MOPP, before ABMT.
© 1999 by The American Society of Hematology.
| |
INTRODUCTION |
ALTHOUGH HODGKIN'S DISEASE is
potentially curable, 30% to 40% of patients develop relapse
after primary treatment.1 After the initial relapse,
response rates to subsequent therapy vary from 0% to 80%, depending
on prognostic factors present at the time of relapse.2
Furthermore, response rates depend on the type and duration of response
attained with the initial therapy.3-5 A Cancer and Leukemia
Group B (CALGB) study has convincingly established the superiority of
ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine)-based
regimens over MOPP (mechlorethamine, vincristine, procarbazine, and
prednisone) alone in the initial treatment of advanced Hodgkin's
disease.1 In that study, patients who had progressive
disease after ABVD subsequently received MOPP. Of these patients, 61%
achieved a second remission, whereas only 35% of those who suffered
relapse after MOPP responded to ABVD. However, other investigators have
suggested that the rates of response to salvage treatment after initial
therapy with MOPP, ABVD, or hybrid regimens are similar.3
Patients with relapsed Hodgkin's disease treated with high-dose
chemotherapy and hematopoietic rescue by autologous bone marrow or
peripheral stem cell have an overall failure-free survival of 30% to
40% at two years.6-9 However, the clinical characteristics of these patients have been very heterogeneous, making it difficult to
define which patients benefit the most from such treatment. Potentially
important features that determine results after high-dose therapy and
stem cell rescue include prognostic factors at the time of relapse, the
type of conditioning regimen used at the time of transplant, and
possibly the cytoreductive or debulking regimen used before the
high-dose conditioning regimen.
In this study, we uniformly treated patients with relapsed Hodgkin's
disease, who were potential candidates to receive high-dose chemotherapy, with a novel combination called ASHAP (Adriamycin = doxorubicin, Solumedrol = methylprednisolone, High-dose Ara-C = cytosine arabinoside, and Platinum = cisplatinum) for tumor mass
reduction before high-dose chemotherapy. The selection of this regimen
was based on preceding results by Velasquez et al10 suggesting that this combination is an active treatment of relapsing disease in patients who had previously received both alkylating agents
and doxorubicin. Our aims were to determine the response rate of
relapsed or refractory Hodgkin's disease to this regimen before
intense-dose consolidative ABMT (high-dose chemotherapy with autologous
marrow or stem cell rescue), and to use an abbreviated number of treatments to minimize toxicity. The results show that the
regimen ASHAP is an effective cytoreductive combination in patients
with Hodgkin's disease previously treated with chemotherapy.
| |
MATERIALS AND METHODS |
Patient population.
Fifty-seven patients with relapsing Hodgkin's disease were treated
with ASHAP. One patient was retrospectively diagnosed as having T-cell
rich, B-cell large cell lymphoma, and was excluded from the analysis.
To be enrolled in this study, patients had to be more than 15 and less
than 61 years old, have a performance status 2 by Zubrod's scale,
and meet the following criteria: histologically proven relapsed
Hodgkin's disease, after prior chemotherapy with either or both MOPP
and ABVD, or other comparable regimens; measurable tumor masses;
adequate hematopoiesis defined as granulocytes  1500/uL, platelet
count 100,000/uL; adequate renal function defined as creatinine 1.5
mg/dL; adequate liver function defined as bilirubin 1.5 mg/dL, serum
glutamic pyruvic transaminase (SGPT) 4× upper
normal limit; adequate pulmonary function defined as forced vital
capacity (FVC) 70% and diffusion capacity of carbon
monoxide (DLCO) 50%, unless abnormal due to Hodgkin's
disease in the lungs; and cardiac left ventricular ejection fraction
50%. Patients were required to have had no chemotherapy, radiation
therapy, or immunotherapy for 3 weeks before start of treatment.
Evaluation.
Before therapy, all patients underwent a complete history and physical
examination, including evaluation of performance status, presence of
constitutional symptoms, and concurrent nonmalignant disease and its
therapy. All prior anticancer treatments were recorded, with specific
notation of cumulative anthracycline dose.
Laboratory studies included a complete blood count (CBC), platelet,
differential, SMA-12 (glucose, blood urea nitrogen, uric acid, calcium,
phosphorus, total protein, albumin, creatinine, total bilirubin,
alkaline phosphatase, serum glutamic pyruvic transaminase, and lactic
dehydrogenase), prothrombin time (PT), partial thromboplastin time (PTT), urinalysis, and
electrolytes. Appropriate radiological and radioisotope examinations
for measurement or evaluation of disease, including gallium scans, were
done within 4 weeks of starting treatment. Further tests included
bilateral bone marrow aspiration and biopsy, spirometry, DLCO,
electrocardiogram (EKG), cardiac scan or 2-D echocardiogram,
cytomegalovirus (CMV) titer, herpes simplex serology, human
immunodeficiency virus (HIV) antibody, human T-cell lymphotrophic virus
type-1 (HTLV-1) antibody, and serologies for hepatitis A, B, C, and
Epstein-Barr virus (EBV) antibody.
During treatment all patients had weekly monitoring of their CBC,
differential and platelet counts, and before each treatment cycle
SMA-12, urinalysis, and electrolytes, including magnesium, were
monitored. After the first two treatment cycles, any radiographic or
radioisotope studies pertinent to measurable or evaluable disease were
repeated, including gallium scan testing.
Treatment plan.
Patients received two cycles of ASHAP chemotherapy, consisting of
doxorubicin 10 mg/m2/d intravenous (IV) continuous infusion
(CI) over 24 hours, days 1 to 4, via central venous catheter (CVC);
cisplatinum 25 mg/m2/d IV CI over 24 hours, days 1 to 4, also via CVC; cytosine arabinoside 1.5 g/m2 IV over 2 hours
after completion of cisplatinum (day 5); and methylprednisolone 500 mg
IV over 15 minutes daily × 5 days. After two cycles of ASHAP,
patients underwent evaluation for response. Those with progressive
disease were removed from this study. All others, including those with
minor response or stable disease, underwent autologous bone marrow
harvest and storage. While awaiting confirmation of marrow viability or
insurance clearance, these patients received a third cycle of ASHAP.
Subsequently, they received high-dose chemotherapy consolidation and
hematopoietic rescue by reinfusion of their harvested marrow, according
to previously published protocol.7
Statistical methods.
Complete response (CR) was defined as complete disappearance by
physical exam and radiographic studies, of all measurable or evaluable
disease, with no indication of recurrence before the high-dose
chemotherapy consolidation. Partial response was defined as 50%, but
<100% improvement in all measurable or evaluable disease, with no
indication of tumor regrowth before high-dose chemotherapy
consolidation. Overall survival was measured from the time of
registration on study. Curves were constructed using the method of
Kaplan and Meier.11 Differences in survival between groups
according to the different covariates were analyzed by the generalized
log-rank test.12 The significance of differences in the CR
rates according to various features was calculated by Chi square
testing.13
| |
RESULTS |
The patients had a median age of 29 years (range 18 to 56), and the
group had a balanced ratio of males and females
(Table 1). The clinical features of the
group were generally unfavorable. The majority of patients had
extensive disease at relapse, and 38% had B symptoms. Sixty-two
percent had received more than one chemotherapy regimen before ASHAP,
and most had received both doxorubucin and alkylator regimens. In
addition, most had prior remissions of less than 12 months' duration.
Response to ASHAP.
Nineteen patients (34%) achieved CR and 20 (36%) achieved partial
response (PR) with two cycles of ASHAP for a total response rate of
70%. Eight (14%) achieved a minor response, whereas 9 (16%) had
progressive disease. The latter were removed from this study and
received treatment according to other protocols including autologous
bone marrow transplant (3 patients), antiferritin radioactive polyclonal antibody (2 patients), and other salvage chemotherapy regimens (4 patients).
Factors predicting poor response to ASHAP were the presence of B
symptoms at relapse and a duration of response to the most recent past
therapy of 6 months' duration. Other factors that had no significant
influence on the response rate to ASHAP included stage, the number of
extranodal sites, duration of initial remission, and prior radiotherapy
(Table 2).
Toxicity.
There were no deaths due to toxicity of ASHAP and no grade-III or -IV
nonhematologic toxicities. None of the patients suffered cardiac or
renal toxicity. By the National Cancer Institute (NCI) common toxicity criteria, all patients developed grade-III or -IV
neutropenia, which was reversible, and grade-II to -III
thrombocytopenia, also reversible.
Overall survival (OS) analyses.
At the time of this analysis, 23 out of 56 (41%) patients were alive.
Of the 33 deaths, 2 were due to causes other than Hodgkin's disease: 1 of a heart attack, and the other a second neoplasia. The median
survival and event-free survival were 37 and 16 months, respectively.
At 4 years the survival was 41% (95% confidence interval [CI] 28%
to 54%) and the event-free survival was 36% (95% CI, 23% to 49%)
(Fig 1A, B). The response to ASHAP
correlated with the long-term probability of surviving the disease,
although survival in this patient population is the result of the total treatment (Fig 2). None of the 17 patients
whose disease failed to respond to ASHAP (including the 8 that achieved
a minor response) is alive at 4 years (P = .00017).
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| Fig 1.
Overall survival (A) and event-free survival (B) in the
56 evaluable patients enrolled on study.
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| Fig 2.
Overall survival according to response to ASHAP. All
patients underwent ABMT after ASHAP with the exception of 2 patients
who received polyclonal antiferritin antibodies, and 3 had other
chemotherapy salvage regimens.
|
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The mortality rate, due to causes other than disease, was 8% in the
group of 47 patients who underwent the transplant after responding to
ASHAP. Two patients died of acute transplant-related toxicity, 1 patient died of a heart attack, and 1 died of myelodysplastic syndrome.
We performed a limited univariate analysis of recognized prognostic
factors for survival in this disease other than response to salvage
therapy. Specifically, we analyzed the significance of the patients'
sex and age, the stage of disease at diagnosis and relapse, duration of
initial remission, and B symptoms. Only B symptoms at relapse and
extranodal disease at relapse were associated with a worse outcome
(P = .008 and P = .005, respectively)
(Table 3).
There were no significant differences in the survival between the
patients who achieved a CR to ASHAP versus those who achieved a PR as
measured by standard radiological studies (ie, computed tomography
[CT] scans, chest radiograph [CXR]). However, as indicated in the
text, there was a difference in the survival between the patients whose
tumor masses became Gallium negative versus those who did not. All of
the patients had positive gallium scans before entering the study, and
41 (including 19 patients in clinical CR, 20 patients in clinical PR,
and 2 minor responses [MR]) had follow-up gallium scans after ASHAP.
In 23 cases (57%), the gallium scan became negative after ASHAP,
including all 19 patients who were deemed to be in CR and 4 additional
patients whose disease response had been designated as PR by CT scans.
These 23 patients with negative gallium scans had a survival rate of
60% at 5 years, compared with 35% for the 18 who still had positive
gallium scans after ASHAP (P = .056)
(Fig 3).
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| Fig 3.
Overall survival of 41 patients who had both pre- and
post-ASHAP gallium. According to gallium response, 23 became gallium
negative (19 clinical CR + 4 clinical PR) whereas 18 remained gallium
positive (16 clinical PR + 2 minor responses).
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| |
DISCUSSION |
ASHAP is an active regimen in the treatment of relapsed Hodgkin's
disease. Velasquez et al10 reported a response rate of 87%, with 56% CR in 16 patients with either relapsed or refractory Hodgkin's disease treated with ASHAP, all of whom had previously received doxorubicin-based chemotherapy. In that pilot study, patients
with chemosensitive disease were administered six cycles of ASHAP. In
the current report, we treated a larger number of patients and most of
them (84%) had also previously received therapy with anthracyclines.
Moreover, disease response in our study was assessed after only two
cycles of ASHAP, with a maximum treatment of three cycles. Our goal was
to debulk disease but yet minimize toxicity, anticipating further
treatment with ABMT consolidation. The overall response rate was 70%,
confirming the favorable activity of this drug regimen.
Other than the above study by Velasquez et al,10 there is
only minimal data on the efficacy of Ara-C and Platinum in Hodgkin's disease.14,15 The study by Rapoport et al15
shows a response rate of 47% in 19 patients with relapsing Hodgkin's
disease treated with DHAP (Decadron-dexamethasone, high dose
Ara-C-cytosine arabinoside, Platinum-cisplatinum) before autologous
stem cell transplant. Several studies, however, have been performed
with various other salvage regimens after MOPP, ABVD, or both. In the
CALGB trial, 61% of patients in whom ABVD failed as initial therapy
achieved a CR with MOPP, and the 3-year failure-free survival of 40%
of that group is encouraging.1 However, the CALGB results
are different from those reported by Viviani et al16 who
reported that MOPP achieved a CR in only 25% of patients whose
Hodgkin's disease failed to respond to ABVD. Moreover, the toxicities
associated with MOPP as relapse therapy, and the fact that many
patients receive both MOPP and ABVD as initial therapy, make the design of alternative salvage regimens a priority goal.
The CEP regimen (CCNU [lomustine], Etoposide, and
Prednimustine) produced a 30% CR rate in patients with resistant
Hodgkin's disease.17 Investigators have reported that
other etoposide-based regimens, such as CEVD (lomustine, etoposide,
vindesine, dexamethasone), CAV (lomustine, melphalan, etoposide) or EVA
(etoposide, vinblastine, and doxorubicin), yield similar
overall results.18-20 We investigated the efficacy of MIME
(Methylguazone, Ifosfamide, Methotrexate, and Etoposide) in patients
treated with both MOPP and ABVD or CVPP (lomustine, vinblastine,
procarbazine, and prednisone)/ABDIC (doxorubicin, bleomycin,
decarbazine, lomustine, prednisone).21 The CR rate in those
patients was 23%. Thus, the CR rate to ASHAP in this study (34%), in
patients mostly treated with both MOPP and ABVD or ABV, seems at least
comparable to those reported for etoposide-based regimens. In addition,
this CR rate was achieved with only two treatments, which would
minimize morbidity before ABMT. Interestingly, there were no
differences in the response rate to ASHAP amid the few patients who
received MOPP versus those who received ABVD before ASHAP.
Four patients who had PR due to persistent masses by CT had negative
gallium scans after ASHAP, whereas none of the patients who achieved
clinical CR were gallium positive. The discordant readings of clinical
PR and negative gallium were due to residual mass effect in areas of
initially bulky disease, which can cause difficulty in distinguishing
persistent active disease versus scar effect. Patients whose gallium
scans became negative after ASHAP had a 60% survival rate, compared
with 35% for those whose scans remained positive. On the other hand,
there was no significant difference in the survival between those
patients in CR versus PR to ASHAP, as defined by standard radiological
studies (CXR and CT scans). Thus, our data suggests that gallium
scanning is a useful adjunct to prognostic assessment of the potential
benefit from high-dose chemotherapy consolidation subsequent to
initial cytoreduction.
In conclusion, our study shows that ASHAP is an effective cytoreductive
treatment in patients with refractory or relapsing Hodgkin's disease
before high-dose chemotherapy. It was beneficial in a group of patients
who had predominantly received prior anthracycline-containing chemotherapy regimens. Treatment duration before consolidation with
high-dose chemotherapy was brief, and no serious life-threatening toxicities were noted.
| |
FOOTNOTES |
Submitted August 11, 1998; accepted January 20, 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 M. A. Rodriguez, MD, Department of Lymphoma
and Myeloma, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Boulevard, Box 68, Houston, TX 77030.
| |
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ABSTRACT
INTRODUCTION