The document summarizes updated 2006 recommendations from ASCO for the use of hematopoietic colony-stimulating factors (CSFs). Key recommendations include: - Primary CSF prophylaxis is recommended when the risk of febrile neutropenia is 20% or higher. - Secondary CSF prophylaxis is recommended for patients who experienced a prior neutropenic complication. - Therapeutic CSF use should be reserved for high-risk patients with fever and neutropenia. - CSF can increase dose-dense chemotherapy but should only be used in clinical trials.

1. What’s New in JCO
2006 Update of ASCO Practice Guideline Recommendations
for the Use of White Blood Cell Growth Factors:
Guideline Summary
Context 4. Use of CSF to Increase Chemotherapy Dose
ASCO convened an Update Committee composed of the Intensity and Dose Density
original Expert Panel and select ad hoc members to present Data on using CSF to increase dose-intensity or -density
the 2006 evidence-based clinical practice guideline update
chemotherapy regimens are limited. Evidence has shown that
(J Clin Oncol 24:3187-3205, 2006) for the use of
the use of CSF allows for a moderate increase in dose-dense
hematopoietic colony-stimulating factors (CSF).
(but not dose-intense) regimens in certain settings (e.g., node-
positive breast cancer; and possibly non-Hodgkin’s
Updated 2006 Recommendations lymphoma pending confirmation of results of individual
See Table 1 for a summary of the updated 2006 trials). This treatment approach should only be used within
recommendations and specific considerations. Table A1 lists the constructs of a clinical trial or if supported by
the incidence of toxicities associated with selected appropriate evidence.
chemotherapy regimens.
1. Primary Prophylactic CSF Administration 5. Use of CSF As Adjuncts to Progenitor-
(first and subsequent-cycle use) Cell Transplantation
Clinical trial data support the use of CSF when the risk of Major complications of high-dose chemotherapy supported
febrile neutropenia (FN) is in the range of 20% or higher. by autologous bone marrow transplantation or peripheral-
This recommendation represents a departure from the 2000 blood progenitor cell (PBPC) transplantation include disease
update, which recommended the use of CSF when the risk of recurrence, infection, delayed or incomplete engraftment, and
FN was 40% or higher. Most commonly used regimens have organ damage from the ablative regimen. The use of CSF to
an FN risk of less than 20%. Oncologists should consider the mobilize PBPC and to shorten the period of neutropenia after
optimal chemotherapy regimen, individual patient risk factors cytoreduction and PBPC transplantation is well established.
and treatment intention when deciding whether to use
prophylactic CSF. The use of regimens that do not require
6. Use of CSF in Patients With Acute Leukemia and
CSF because of equal efficacy and lower risk of FN remains
standard medical practice. Myelodysplastic Syndromes
Considerations and available evidence vary for acute myeloid
2. Secondary Prophylactic CSF Administration leukemia (AML), myelodysplastic syndrome (MDS), acute
Secondary prophylaxis with CSF is recommended for a select lymphocytic leukemia (ALL), and acute leukemia in relapse.
group of patients. Oncologists should be mindful of previous Several studies have shown that CSF administration can
neutropenic complications, prior CSF administration, and produce modest decreases in the duration of neutropenia
appropriateness of dose reduction. No definitive conclusions when begun shortly after completion of the initial induction
can be drawn regarding the benefits of secondary prophylaxis chemotherapy for patients with AML. Studies on CSF
on survival, quality of life, or cost. priming of leukemia cells in patients with AML produced
results showing no effect on complete response rates or overall
3. Therapeutic Use of CSF survival. Additional studies on AML patients (those in
Therapeutic intervention with CSF can help reduce the remission) showed a seemingly profound shortened duration
incidence of infectious episodes and infection-related of neutropenia after consolidation chemotherapy. These
morbidity and mortality. However, therapeutic CSF use studies produced no effect on complete response duration or
should be reserved for patients with fever and neutropenia overall patient survival. Though CSF use can increase the
and those at high risk for infection-associated complications absolute neutrophil count in neutropenic patients with MDS,
or poor clinical outcomes. This intervention should not be data supporting the routine, long-term, continuous use of
routinely used in afebrile patients or FN patients receiving CSF for this population are lacking. Using CSF for patients
antibiotic therapy. Clinical prediction models have been with ALL (after initial chemotherapy induction or
developed to help prospectively identify patients with cancer postremission course) may shorten the duration of
who are at higher risk of complications as a result of fever and neutropenia by 1 week. However, CSF use in patients with
neutropenia; a risk model for mortality in hospitalized relapsed or refractory acute leukemia may provide only a few
patients has also been reported recently (Table 2). days of shortened neutropenia.
196 JOURNAL OF ONCOLOGY PRACTICE • V O L . 2, I S S U E 4 Copyright © 2006 by American Society of Clinical Oncology.
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2. Table 1. Summary of 2006 Recommendations for the Use of CSF
Setting/Indication Recommendation
Primary prophylaxis Primary prophylaxis is recommended for the prevention of FN in patients who have a high risk of FN based on
age, medical history, disease characteristics, and myelotoxicity of the chemotherapy regimen. For “dose-dense”
regimens, CSF is required and recommended. Clinical trial data support the use of CSF when the risk of FN is in
the range of 20% or higher.
Primary prophylaxis: Special Certain clinical factors predispose to increased complications from prolonged neutropenia, including: patient age
circumstances 65 years; poor performance status; previous episodes of FN; extensive prior treatment including large radiation
ports; administration of combined chemoradiotherapy; bone marrow involvement by tumor-producing
cytopenias; poor nutritional status; the presence of open wounds or active infections; more advanced cancer, as
well as other serious comorbidities. In such situations, primary prophylaxis with CSF is often appropriate, even
with regimens with FN rates of 20%.
Secondary prophylaxis Secondary prophylaxis with CSF is recommended for patients who experienced a neutropenic complication from
a prior cycle of chemotherapy (for which primary prophylaxis was not received), in which a reduced dose may
compromise disease-free or overall survival or treatment outcome. In many clinical situations, dose reduction or
delay may be a reasonable alternative.
Therapeutic use: Afebrile CSF should not be routinely used for patients with neutropenia who are afebrile.
neutropenia
Therapeutic use: Febrile CSF should not be routinely used as adjunctive treatment with antibiotic therapy for patients with fever and
neutropenia neutropenia. However, CSF should be considered in patients with fever and neutropenia who are at high-risk for
infection-associated complications, or who have prognostic factors that are predictive of poor clinical outcomes.
High-risk features include expected prolonged ( 10 days) and profound ( 0.1 109/L) neutropenia, age 65
years, uncontrolled primary disease, pneumonia, hypotension and multi-organ dysfunction (sepsis syndrome),
invasive fungal infection, or being hospitalized at the time of the development of fever.
Dose intensity/density of Dose-dense regimens should only be used within an appropriately designed clinical trial or if supported by
chemotherapy convincing efficacy data.
Adjuncts to progenitor-cell Administration of CSF to mobilize PBPC often in conjunction with chemotherapy, and their administration after
transplantation autologous, but not allogeneic, PBPC transplantation is the current standard of care.
AML: Initial or repeat CSF use following initial induction therapy is reasonable, though there has been no favorable impact on remission
induction chemotherapy rate, remission duration, or survival. Patients 55 years of age may be most likely to benefit from CSF use.
AML: CSF for priming Use of CSF for priming effects is not recommended.
effects
AML: Consolidation CSF use can be recommended after the completion of consolidation chemotherapy because of the potential to
chemotherapy decrease the incidence of infection and eliminate the likelihood of hospitalization in some patients receiving
intensive postremission chemotherapy. There seems to be more profound shortening of the duration of
neutropenia after consolidation chemotherapy for patients with AML in remission than for patients receiving initial
induction therapy. As yet there is no information about the effect of longer-acting pegylated CSFs in patients with
myeloid leukemias, and they should not be used in such patients outside of clinical trials.
MDS Intermittent administration of CSF may be considered in a subset of patients with severe neutropenia and
recurrent infection.
ALL CSF administration is recommended after the completion of the initial first few days of chemotherapy of the initial
induction or first postremission course, thus shortening the duration of neutropenia of 1,000/mm3 by
approximately 1 week.
Acute leukemia in relapse CSF should be used judiciously, or not at all, in patients with refractory or relapsed myeloid leukemia since the
expected benefit is only a few days of shortened neutropenia.
Radiotherapy CSF should be avoided in patients receiving concomitant chemotherapy and radiation therapy, particularly
chemotherapy involving the mediastinum. In the absence of chemotherapy, therapeutic use of CSF may be considered in
patients receiving radiation therapy alone if prolonged delays secondary to neutropenia are expected.
Older patients Prophylactic CSF for patients aged 65 years with lymphoma treated with curative chemotherapy (CHOP or
more aggressive regimens) should be given to reduce the incidence of FN and infections.
Pediatric patients As in adults, the use of G-CSF is reasonable for the primary prophylaxis of pediatric patients with a likelihood of
FN. Similarly, the use of G-CSF for secondary prophylaxis or for therapy should be limited to high-risk patients.
However, the potential risk for secondary myeloid leukemia or myelodysplastic syndrome associated with G-CSF
represents a concern in children with ALL whose prognosis is otherwise excellent. For these reasons, the specific
use of G-CSF in children with ALL should be considered carefully.
Continued on next page
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3. Table 1. Summary of 2006 Recommendations for the Use of CSF (continued)
Setting/Indication Recommendation
Comparative clinical activity No guideline recommendation can be made regarding the equivalency of the two colony-stimulating agents.
of G-CSF and GM-CSF Further trials are recommended to study the comparative clinical activity, toxicity, and cost-effectiveness of G-
CSF and GM-CSF.
Treatment for radiation Current recommendations for the management of patients exposed to lethal doses of total-body radiotherapy,
injury but not doses high enough to lead to certain death due to injury to other organs, includes the prompt
administration of CSF or pegylated G-CSF.
Abbreviations: CSF, colony-stimulating factors; FN, febrile neutropenia; PBPC, peripheral-blood progenitor cell; AML, acute myeloid leukemia;
MDS, myelodysplastic syndrome; ALL, acute lymphocytic leukemia; CHOP, cyclophosphamide, doxorubicin, vincristine, prednisone; G-CSF,
filgrastim; GM-CSF, sargramostim; pegylated G-CSF, pegfilgrastim.
7. Use of CSF in Patients Receiving Radiotherapy 9. Use of CSF in the Pediatric Population
With or Without Concurrent Chemotherapy The use of CSF in pediatric patients will almost always be
Though concurrent chemotherapy with radiation therapy is guided by clinical protocols. Several multicenter randomized
important in certain treatment settings, oncologists should clinical trials have evaluated prophylactic CSF in children,
avoid CSF administration for these patients. However, in the particularly those with acute leukemia. Based on this research,
absence of chemotherapy, and if prolonged delays secondary oncologists should consider cautiously the use of CSF in
to neutropenia are expected, patients receiving radiation children with ALL. When determining whether CSF
therapy alone may benefit from the therapeutic use of CSF. administration would prophylactically or therapeutically
benefit a pediatric patient, the oncologist should consider the
patient’s likelihood of developing FN and incidence of other
8. Use of CSF in Older Patients: New Topic risk factors.
Aging is one of the conditions for which prophylactic use of
growth factors may be indicated irrespective of the threshold
risk of neutropenia. However, aside from data available in 10. CSF Initiation, Duration, Dosing,
patients with lymphoma, there is insufficient evidence to and Administration
support the use of prophylactic CSF in patients, based solely Filgrastim (G-CSF), pegfilgrastim (pegylated G-CSF), and
on age. Oncologists should consider additional patient risk sargramostim (GM-CSF) are the growth factors currently in
factors when deciding whether to administer CSF to use. The administration protocol for each agent varies
elderly patients. according to setting (Table 3).
Table 2. Clinical Prediction and Risk Models
Clinical Prediction Model for Prospectively Risk Model for Mortality in Hospitalized Patients: Independent Risk Factors
Identifying Cancer Patients at Higher Risk of for Inpatient Mortality in Hospitalized Patients With FN
Complications due to Fever and Neutropenia:
Reported Risk Factors for Serious Medical
Complications in Patients With Established FN
Development of FN as inpatient Comorbidities: CHF, PE, lung, renal, liver, and cerebrovascular disease
Hypotension Infectious complications: hypotension, pneumonia, bacteremia, fungal infection
Sepsis Cancer type (leukemia, lung cancer)
Cardiovascular disease Age 65 years
Pulmonary disease
Leukemia or lymphoma diagnosis
Age 65 years
Prior fungal infection
Visceral organ involvement
Organ dysfunction
Uncontrolled malignancy
Severity and duration of neutropenia
Abbreviations: FN, febrile neutropenia; CHF, congestive heart failure; PE, pulmonary embolism.
198 JOURNAL OF ONCOLOGY PRACTICE • V O L . 2, I S S U E 4 Copyright © 2006 by American Society of Clinical Oncology.
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4. Table 3. Recommendations for CSF Initiation, Duration, Dosing, and Administration
Growth Factor Setting Initiation Duration Dose
G-CSF (filgrastim) Myelotoxic chemotherapy 24-72 hours after Continue until ANC at least Adults: 5 g/kg/d
administration of 2-3 109/L subcutaneous
chemotherapy
High-dose therapy and 24-120 hours after Continue until ANC at least Adults: 5 g/kg/d
autologous stem-cell administration of high- 2-3 109/L subcutaneous
rescue dose therapy
PBPC mobilization Start at least 4 days before Continue until last Adults: 10 g/kh/d
first leukapheresis leukapheresis subcutaneous
Pegylated G-CSF Myelotoxic chemotherapy 24 hours after completion Once in each 6 mg†
(pegfilgrastim)* of chemotherapy chemotherapy cycle
GM-CSF (sargramostim)‡ Bone marrow Day of bone marrow Continue until ANC 1.5 Adults: 250 g/m2/d for all
transplantation or AML infusion and not less than 109/L for 3 consecutive clinical settings other than
24 hours from the last days§ PBPC mobilization
chemotherapy and 12
hours from most recent
radiotherapy
NOTE. The long-term effects of long acting growth factors are unknown, and the Update Committee expressed concern about potential
leukocytosis, late neutropenia after discontinuation of pegylated G-CSF, and the need for long-term safety data.
Abbreviations: G-CSF, filgrastim; ANC, absolute neutrophil count; PBPC, peripheral-blood progenitor cell; pegylated G-CSF, pegfilgrastim; GM-
CSF, sargramostim.
* Pegfilgrastim is not currently indicated for stem-cell mobilization. The safety and efficacy of pegylated G-CSF has not yet been established in the
setting of dose-dense chemotherapy.
† The 6-mg formulation should not be used in infants, children, or small adolescents weighing 45 kg.
‡ Because GM-CSF has been licensed specifically for use after autologous or allogeneic BMT and for AML, the manufacturer’s instructions for
administration are limited to those clinical settings.
§ The drug should be discontinued early or the dose be reduced by 50% if the ANC increases to 20 109/L.
11. Special Comments on Comparative Clinical based on improvements in survival, quality of life, toxicity
Activity of G-CSF and GM-CSF reduction, and cost-effectiveness. The Committee agreed
No guideline recommendation can be made regarding the unanimously that reduction in FN was an important clinical
equivalency of the two colony-stimulating agents. As in 2000, outcome that justified use of CSF, regardless of impact on
further trials are recommended to study the comparative other factors, when the risk of FN was about 20% and no
clinical activity, toxicity, and cost-effectiveness of G-CSF other equally effective regimen that did not require CSF
and GM-CSF. was available.
12. Special Comments on Growth Factors As a
Treatment for Radiation Injury: New Topic
Methodology
Current recommendations for the management of patients The 2006 Update Committee performed a complete
exposed to lethal doses of total-body radiotherapy, but not literature review and analysis of data published from 1999
doses high enough to lead to certain death due to injury to through September 2005. Whenever possible, the Committee
other organs, includes the prompt administration of CSF or focused on randomized controlled trials and systematic
pegylated G-CSF.
reviews and meta-analyses of published trials.
13. Impact of CSF on Quality of Life and Health
Care Costs
Growth factors should be used when indicated for clinical Additional Resources
reasons, not economic ones. When available, alternative The 2006 Update is available in the July 1, 2006, print
regimens offering equivalent efficacy but not requiring CSF edition of JCO and also at www.jco.org (J Clin Oncol
support should be utilized. Further research into CSF cost 24:3187-3205, 2006). In addition to the full text of the
implications and impact on quality of life is warranted. guideline recommendations, available online at http://
www.asco.org/guidelines/wbcgf, further resources from
Discussion ASCO include a patient guide and PowerPoint slide set.
The 2006 Update Committee was guided by the 1996 ASCO A CSF flow sheet and orders form is available online at
outcomes criteria that justify the use of a drug or technology www.jopasco.org.
Copyright © 2006 by American Society of Clinical Oncology. J U L Y 2006 • www.jopasco.org 199
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5. The ASCO 2006 Update of Recommendations for the Use of Jeffrey Crawford, Scott J. Cross, George Demetri,
White Blood Cell Growth Factors was developed and written by Christopher E. Desch, Philip A. Pizzo, Charles A. Schiffer,
Thomas J. Smith (Chair), James Khatcheressian, Gary H. Lee Schwartzberg, Mark R. Somerfield, George Somlo,
Lyman, Howard Ozer, James O. Armitage, Lodovico James C. Wade, James L. Wade, Rodger J. Winn,
Balducci, Charles L. Bennett, Scott B. Cantor, Antoinette J. Wozniak, and Antonio C. Wolff.
It is important to realize that many management questions have not been comprehensively addressed in randomized trials and
guidelines cannot always account for individual variation among patients. A guideline is not intended to supplant physician
judgment with respect to particular patients or special clinical situations and cannot be considered inclusive of all proper methods of
care or exclusive of other treatments reasonably directed at obtaining the same results.
Accordingly, ASCO considers adherence to this guideline to be voluntary, with the ultimate determination regarding its application
to be made by the physician in light of each patient’s individual circumstances. In addition, the guideline describes administration
of therapies in clinical practice; it cannot be assumed to apply to interventions performed in the context of clinical trials, given that
clinical studies are designed to test innovative and novel therapies in a disease and setting for which better therapy is needed.
Because guideline development involves a review and synthesis of the latest literature, a practice guideline also serves to identify
important questions for further research and those settings in which investigational therapy should be considered.
Assess and Improve Care in Your Medical Oncology Practice
The goal of ASCO’s Quality Oncology Practice Initiative (QOPI) is to promote excellence in cancer care by helping
medical oncologists create a culture of self-examination and improvement.
QOPI practices benefit from knowledge of practice strengths and weaknesses and access to tools and strategies to
improve care. By participating in QOPI, physicians receive practice-specific data, aggregate data from their peers
for comparison, and access to resources for implementing best practices. All practice-specific data are released only to
that practice, and are kept strictly confidential.
Join the oncologist-led initiative for assessing and improving care
in medical oncology practice.
Visit www.asco.org/QOPI. AMERICAN SOCIETY OF CLINICAL ONCOLOGY
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6. Table A1. Incidence of Hematologic and Infectious Toxicities Associated With Selected Chemotherapy Regimens
No. of Grade 4 Grade 4 Grade ≥ 2 Grade ≥ 3
Cancer Stage and Prior Patien Leukopenia Neutropenia Febrile Fever Infection Infectious
Histology Therapy Regimen ts (%)* (%) Neutropenia (%) (%)‡ (%)§ Death (%)
Adult AML Newly diagnosed Ara-C/DNR 163 93 — — 37 (no 64 12
infection)
AIDS-related Advanced/1st and 2nd Lipo Dox [+G(M)-CSF] 133 36 (3+4) 6 — 1 — 0
Kaposi's sarcoma line VP–16 (oral) 36 — 19.4 — 8 — —
Paclitaxel 56 — 35 — — — —
AIDS-related† Intermediate- and high- CHOP (Modified) 40 — 25 (3+4) 2.5 — — 10
NHL grade, untreated CHOP + G-CSF 25 — 13 (3+4) 0 — — —
Bladder Advanced, no prior GC 203 — 29.9 2 0 2.5 1
systemic therapy MVAC 202 — 65.2 14 3.1 15.1 2.5
Prior adjuvant allowed CBDCA/Pac ± G-CSF 33 — 21 21 — 1 patient sepsis 0
Breast Adjuvant CA (60 mg/m2) 1060 — 62 10 (hospitalized) — 17 0
CA→T (all dose levels) 1590 — 16 3 — 11 0
CEF 351 49.9 89.7 8.5 — — 0
TAC 109 — — 23.8 — — —
Adjuvant (dose dense) A→T→C 484 1 24 3 — 3 0
A→T→C + G-CSF 493 — 3 2 — 4 0
AC→T 501 11 43 6 — 5 0
495 6 9 2 — 3 0
AC→T + G-CSF
Metastatic (1st line) 165 — 77.8 12.3 — 4.3 1 death
A (75) 161 — 78.6 5.7 — 2.5 1 death
Doc (100) 215 — 88 (3+4) 10 — 2 0.5
AC 214 — 97 (3+4) 33 — 8 0
AT 54 — 100 (3+4) 34 — 2 0
TAC
Metastatic (2nd line) 255 — 11 16 — — <1
Cap Doc 256 — 12 21 — — 0
Doc
Colorectal Adjuvant 5-FU/LV/L 449 2 — — — — <1
5-FU/LV 116 15 (high LV) — — — — 1.7
22 (low LV)
Advanced IFL 189 — 24 7.1 — 1.8 <1
FL 226 — 42.5 14.6 — 0 1.4
I 226 — 12.1 5.8 — 2.2 <1
FOLFOX4 152 — 17 6 — — 0
FOLFIRI 145 20.4 (3+4) 28.8 (3+4) 9.3 — 1.9 <1
Advanced (one prior CPT-11 (350 mg/m2 Q3 213 36 (3+4) 48 (3+4) 14 — <1 3 deaths
chemo allowed) wk)
Gastric Advanced ECF (infusion) 289 13 32 — 1 6 <1
Germ cell Advanced BEP 141 — 34 (all heme 60 — — — 2
VIP 145 — toxicities) — — — 2.8
Relapsed VeIP 135 — — 71 — — 2.1 (all
deaths)
Head/neck Recurrent; metastatic FU/CBDCA 86 2.3 1.2 — — — 1.2
CBDCA/Pac 41 4.9 9.8 — — — 2.4
Cis/Doc 36 — 71 6 — 11 0
Induction Cis/Doc/FU 43 — 95 (3+4) 19 — 2 0
Lung Extensive SCLC Cis/VP-16 159 14 38 — — 8 ≤ 6 (all toxic
No prior treatment CAV 156 28 52 — — 16 deaths)
CBDCA/VP-16 74 5 — — — — ≤ 4 (all toxic
Cis/CPT-11 77 4 25.3 — 1.3 5.3 deaths)
0
Recurrent Topo 107 31.7 70.2 28 — 4.7 2.6
CAV 104 43.6 71.7 26 — 4.8
3.7
Advanced NSCLC Cis/VNR 206 — 59 10 — — 2.9
No Prior Treatment Cis/Pac (24 hr) 288 — 57 16 — 10
Cis/Gem 288 — 39 4 — 7 1
Cis/Doc 289 — 48 11 — 9 2
CBDCA/Pac 290 — 43 4 — 6 1
CBDCA/Doc 406 49.5 (3+4) 74.4 (3+4) 3.7 — 11 2
1
Recurrent (2nd line) Doc (75 mg/m2) 276 40.2 (3+4) — 12.7 — 3.3 —
Pemetrexed 265 5.3 (3+4) — 1.9 — 0
—
—
Lymphoma Relapsed HD; prior MOPP 123 — 22 — 3 (no infection) 13 1
RT only ABVD 115 — 3 — 5 (no infection) 2 0
Intermediate- and high- CHOP 216 25 22 — — 5 (≥ grade 4) 1
grade CHOP-R 33 1.2 58 18 6 6 0
NHL; no prior treatment VAPEC-B 39 — 72 44 — 5 patient 2 deaths
Relapse NHL
ESHAP 122 — 500/_L median 30 — — 4.1
DHAP 90 — 53 48 — 31 11
Multiple myeloma Untreated VAD ± Inf 169 — — — — — 1.2
Recurrent/refractory VAD ± Inf 52 65.4 — — — 32.7 7.7
Ovary Resected, minimal Cis/Pac (24 hours) 400 12 78 Few instances — — —
residual CBDCA/Pac 392 6 72 — — — —
Salvage Topo 139 30.1 82.4 18 — — 0
Sarcoma Advanced, untreated AD 186 32 38 — — — 0
MAID 188 86 79 — — — 3.5
A 263 13 — — 5.3 (all study 11 (all study arms) —
AI 258 32 — — arms) — —
CYVADIC 142 15 — — — —
Special populations NHL, untreated CHOP 197 — — — 5 (3+4) 20 16 patients
(elderly) CHOP-R 202 — — — 2 12 (both arms)
Breast, adjuvant CMF 76 4 (grade 3) — — — — 0
9 9
* Grade 4 leukopenia: WBC count < 1.0 × 10 /L; grade 4 neutropenia: ANC < 0.5 × 10 /L.
† Most patients received antiretroviral therapy and data do not include opportunistic infections.
‡ Common toxicity criteria fever ≥ grade 2; ≥ 38.1°C (≥ 100.5°F).
§ Infection ≥ grade 3: systemic infection requiring hospitalization.
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