Evaluation of febrile neutropenia and myelosuppression in patients receiving FOLFOX/FOLFIRI in gastrointestinal cancer treated with same-day (SD) pegfilgrastim/pegfilgrastim-CBQV (PFG).

311 Background: The National Comprehensive Cancer Network (NCCN) guidelines and the manufacturers of PFG recommend administration at least 24 hours after chemotherapy (CTX). Administering SD PFG carries the potential risk for exacerbation of neutropenia based on analyses in lymphoma and breast cancer regimens; however, little data exists on infusional fluorouracil and SD PFG administration. The availability of biosimilar PFG and increased utilization of growth factors during the COVID-19 pandemic has led to changes in practice for SD PFG administration. This study explored the incidence of febrile neutropenia (FN) and myelosuppression with FOLFOX and FOLFIRI regimens in Gastrointestinal malignancies (GI) to address the safety of SD utilization of PFG. Methods: Patient data was extracted through electronic health records search of ICD-9 and ICD-10 codes for GI malignancies and treated with FOLFOX or FOLFIRI-based regimens from November 2013 to May 2021. SD administration was defined as administration of PFG within 15 minutes after fluorouracil pump disconnect. The primary endpoint of our study was to evaluate the incidence of FN across all CTX cycles for up to four cycles, in SD PFG administration. Secondary outcomes included chemotherapy induced neutropenia (CIN), hospitalizations, and CTX dose reduction or delay. Results: Three hundred and thirty-nine patient charts were reviewed with 55 patients meeting the inclusion criteria. In our study cohort, 72.7% received FOLFOX and 27.2% received FOLFIRI-based regimens. Out of all 194 CTX cycles, 136 (70.1%) cycles received pegfilgrastim and 58 cycles received pegfilgrastim-cbqv (29.9%). Two patients had grade 3/4 CIN (1%), with both cases resulting in FN (1%). Both FN cases resulted in hospitalizations, and dose delays or reductions. Investigation of FN incidences revealed that both patients received CTX with active infections, one case with a urinary tract infection and the other with a chronic gangrene infection. Conclusions: Our study results suggest that SD administration of PFG can be as a safe and effective alternative to 24-hour post-chemotherapy administration in patients receiving FOLFOX or FOLFIRI-based regimens. The incidence of FN was noted to be minimal in our study. Furthermore, no noted increase in myelosuppression was seen in our analysis, as compared to previous studies in breast cancer and lymphoma-based regimens. SD administration not only minimizes travel burdens on long-distance patients but also has allowed for reduction in infusion appointments and therefore possible exposure to the SARS-COV2 virus during the 2020-2021 pandemic. Future prospective studies are warranted in order to elucidate the risk of FN and myelosuppression in patients undergoing chemotherapy for GI malignancies with SD PFG administration.

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An institutional evaluation of the safety and efficacy of same-day administration of pegfilgrastim in patients receiving chemotherapy for lung cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18591 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e18591-e18591

Author(s):

Jamie Vraney ◽

Neda AlRawashdh ◽

Briana Choi ◽

Ivo Abraham ◽

Ali McBride

Keyword(s):

Lung Cancer ◽

Febrile Neutropenia ◽

Retrospective Chart Review ◽

Small Cell ◽

Cancer Center ◽

Lung Cancer Diagnosis ◽

Real World Evidence ◽

Icd 10 ◽

Grade 3 ◽

The University

e18591 Background: Pegfilgrastim is recommended to be administered 24 hours after myelosuppressive chemotherapy (CTX) as prophylaxis for chemotherapy-induced (febrile) neutropenia (CIN/FN). Recent studies have yielded equivocal data on same day versus next day administration of pegfilgrastim. There has been limited real world evidence addressing lung cancer (LC) patients and the use of same day pegfilgrastim. We evaluated our own institutional data on the safety of same day pegfilgrastim administration in LC patients. Methods: A retrospective chart review was performed by searching electronic health records using ICD-9 and ICD-10 codes corresponding with a lung cancer diagnosis between November 1, 2013 and August 31, 2018 at The University of Arizona Cancer Center (UACC). Patients included in the study were 18 years of age or older, diagnosed with biopsy-confirmed lung cancer, treated at UACC, and receiving chemotherapy and pegfilgrastim on the same day. The outcomes of interest included FN incidence after the first cycle and across all cycles of CTX, CIN grade 3/4 and CTX dose delays or hospitalizations due to CIN/FN after first cycle and across all cycles of CTX. Results: 1,181 patient records were reviewed and 114 patients met the inclusion criteria; 87 (76%) patients had non-small cell LC and 27 (24%) patients had small cell LC. The median age was 68 years, 52% of patients had cancer stage of 3 to 4, and 63% of patients had 0-1 ECOG status. The FN risk assessment was mild in 72% of patients. The mean (SD) of baseline absolute neutrophil count was 5.68 (3.09). In total 384 CTX cycles were received. The table shows the results of all intended outcomes. One patient experienced FN after the first cycle of CTX of irinotecan and 5 patients developed 6 FN episodes across all cycles; 2 patients were on carboplatin etoposide; 1 patient on cisplatin etoposide; 1 patient on vinorelbine and 1 patient was on pemetrexed and then on irinotecan CTX when the two FN episodes were developed. Conclusions: This study showing that same day administration of pegfilgrastim was as effective as next day administration in LC patients, without warranting any concerns for febrile neutropenia or delayed engraftment. Utilization of same day pegfilgrastim, in light of biosimilars and COVID, provides a unique opportunity for cancer care without concerns for FN as stated in previous studies.[Table: see text]

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Medical Costs of Adverse Events in Chronic Myeloid Leukemia Patients Treated with Tyrosine Kinase Inhibitors: Canadian Perspective.

Blood ◽

10.1182/blood.v110.11.5178.5178 ◽

2007 ◽

Vol 110 (11) ◽

pp. 5178-5178

Author(s):

Nick Newton ◽

Khalid El Ouagari ◽

Mireille M. Goetghebeur

Keyword(s):

Chronic Myeloid Leukemia ◽

Febrile Neutropenia ◽

Adverse Events ◽

Tyrosine Kinase ◽

Tyrosine Kinase Inhibitors ◽

Myeloid Leukemia ◽

Kinase Inhibitors ◽

Medical Costs ◽

Icd 10 ◽

Grade 3

Abstract Background: Imatinib (Gleevec) is recommended first-line therapy for treatment of chronic myeloid leukemia (CML). A relatively small group of patients treated with imatinib develop resistance or are intolerant to the treatment. Dose escalation of imatinib may be used in some cases. Recently, two treatment options, nilotinib (Tasigna) and dasatinib (Sprycel), have become possible alternatives for patients resistant or intolerant to imatinib. Current data indicates that nilotinib and dasatinib have a different side effect profile. Objectives: This study investigated the costs of adverse events (AEs) in patients receiving nilotinib or dasatinib for chronic and accelerated CML. Methods: Incidence rates of grade 3/4 AEs treated with nilotinib or dasatinib were obtained from nilotinib Phase II Summary of Clinical Safety: 120-Day Safety Update Report and dasatinib product information, respectively. Costs for non-hematological AEs were obtained from the Ontario Case Costing Initiative (OCCI) acute inpatient databases, using ICD-10 codes cross-referenced with AEs described in product monographs. For ICD 10 codes identified for this study, there were not enough cases in CML patients (a minimum of five cases is required to access data) and therefore OCCI costs used in this study were those of AEs in oncology patients. These costs were considered a good approximation of costs of AEs in CML patients by the clinical expert. Costs for grade 3 anemia and thrombocytopenia, and non-febrile neutropenia, were assumed to be outpatient costs and were based on literature, expert validation of treatment pathways and resource utilization in the Canadian context. Costs for grade 4 anemia and thrombocytopenia, and febrile neutropenia, were obtained from the OCCI. Multivariate sensitivity analyses were conducted on costs of AEs. The analysis was developed from a payer perspective considering direct medical costs only. Costs are reported in 2006 Canadian dollars. Results: Cost of treatment-related AEs for CML patients was higher for dasatinib than nilotinib. For both treatments, total costs for AEs associated with the accelerated phase were higher than those associated with the chronic phase: $19,902 versus $7,653 for dasatinib; $8,645 versus $3,790 for nilotinib; respectively. Cost attributable to hematological AEs represented between 45% and 71% of total cost of AEs. Ranking observed among treatments for base case costs of AEs was maintained for both high and low cost estimates, indicating that the model was robust to variation in cost of AEs. Conclusions: For patients resistant or intolerant to imatinib, costs of dasatinib-related AEs were approximately twice the costs of nilotinib-related AEs in both chronic and accelerated phases, highlighting the importance of considering the cost of AEs in economic evaluation of new tyrosine kinase inhibitors. Further research is needed to comprehensively evaluate the impact of AEs on healthcare expenditures.

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UW-01: A randomized comparison of three doses of weekly docetaxel as 1st-line chemotherapy in stage IV breast cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.10522 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 10522-10522

Author(s):

J. R. Gralow ◽

D. Chielens ◽

G. Schuster ◽

B. Storer ◽

M. J. McCleod ◽

...

Keyword(s):

Breast Cancer ◽

Stage Iv ◽

Phase Iii ◽

Study Endpoint ◽

Primary Study ◽

Hematologic Toxicity ◽

Stage Iv Breast Cancer ◽

Study Results ◽

Significant Difference ◽

Grade 3

10522 Background: Docetaxel (DOC) is an active agent in the treatment of breast cancer. The optimal dose and dosing interval for DOC, with respect to balancing efficacy and toxicity, has yet to be determined. In this multi-center, randomized phase III trial, we attempted to compare 3 doses of single-agent weekly DOC. Methods: Patients with documented evaluable or measurable stage IV breast cancer and no prior metastatic chemotherapy were eligible. Prior adjuvant chemotherapy was permitted if ≥ 6 months had elapsed. Adjuvant exposure to DOC was allowed if ≥ 1 year prior. All patients received intravenous weekly DOC, 3 out of 4 weeks. Patients on Arm A received doses of 25 mg/m2, Arm B received 30 mg/m2, and Arm C received 35 mg/m2. The primary study outcome was time to progression (TTP). Secondary endpoints included toxicity, response rate (RR), and overall survival (OS). Targeted accrual was 600 patients. Results: The study was stopped early for feasibility reasons (poor accrual) after a total of 108 patients were enrolled at 49 U.S. sites. The median patient age was 63 years. Grade 3, 4 non-hematologic toxicity was 22%, 22%, and 23% in Arms A, B and C respectively. Nail toxicity of any grade occurred in 2 patients in Arm A, 6 patients in Arm B, and 7 patients (2 of which were grade 3) in Arm C. TTP for Arm A was 19 weeks (95% confidence intervals [CI] 10–23), 28 weeks for Arm B (95% CI 15–38), and 24 weeks for Arm C (95% CI 12–37). There was a marginally significant difference in TTP between arms A and C (HR = 1.7, 95% CI = 1.0–2.8, p = 0.05), but not between arms B and C (HR = 1.0, 95% CI 0.6–1.7, p = 0.94). RR was 26%, 27%, and 31% in Arms A, B and C, respectively. Median survival was 77 weeks for Arm A (95% CI 53–115), and 96 weeks for arm B (95% CI 53-undetermined); it has not yet been reached for Arm C. Discussion: The interpretation of study results is limited due to early stopping and resultant loss of statistical power. For the primary study endpoint, TTP, the lowest (25 mg/m2) dose may be less than optimal, but there was no observed difference between the intermediate (30 mg/m2) and highest doses (35 mg/m2) of weekly DOC. Grade 3, 4 non-hematologic toxicities were similar between the 3 arms. [Table: see text]

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Dose-dense nab-paclitaxel (nanoparticle albumin-bound paclitaxel) in adjuvant chemotherapy for breast cancer: A feasibility study

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.594 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 594-594 ◽

Cited By ~ 1

Author(s):

H. J. Burstein ◽

E. L. Mayer ◽

J. Peppercorn ◽

L. M. Parker ◽

K. Hannagan ◽

...

Keyword(s):

Breast Cancer ◽

Febrile Neutropenia ◽

Patient Scheduling ◽

Full Cohort ◽

Treatment Delays ◽

Grade 3 ◽

Chemotherapy Patients ◽

Dose Dense ◽

Taxane Chemotherapy

594 Background: We sought to evaluate the feasibility of substituting nab-paclitaxel (ABI-007) for paclitaxel as part of “dose-dense” adjuvant sequential doxorubicin / cyclophosphamide (AC) followed by taxane chemotherapy. Patients and Methods: Eligible patients had stage I-III breast cancer receiving adjuvant/neoadjuvant chemotherapy, ANC > 1500, and LVEF > 50%. Patients received AC (60 mg/m2 and 600 mg/m2) every 2 weeks × 4 cycles with G-CSF support, followed by nab- paclitaxel 260 mg/m2 every 2 weeks × 4 cycles. The endpoint was incidence of treatment delay during nab-paclitaxel therapy. Results: 66 women (median age 48 years) were enrolled. Among the first 11 given nab-paclitaxel without G-CSF support, one developed febrile neutropenia, and 4 had nab-paclitaxel treatment delays related to neutropenia (ANC < 1,000). The protocol was amended to require G-CSF support (filgrastim or pegfilgrastim) during nab-paclitaxel. Among the next 55 patients, 3 had febrile neutropenia, none during nab- paclitaxel. In cycles 6–8, nab-paclitaxel was delayed only 6 times (1 neutropenia, 3 hepatic toxicity, 2 patient scheduling); 96% of these cycles were delivered on time. By comparison, 82% of such cycles were delivered on time in a prior institutional study using paclitaxel. In the full cohort, 8 patients had nab-paclitaxel dose reduction, 4 for neuropathy, while other neuropathy was moderate (grade 2, n = 6; grade 3, n=1; grade 4, n=0). Conclusions: Administration of nab-paclitaxel every 2 weeks is feasible but requires G-CSF support. Data comparing nab-paclitaxel dose-delivery, toxicities and quality of life to paclitaxel as seen in prior studies will be presented. No significant financial relationships to disclose.

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Inclusion of Platinum Agents in Neoadjuvant Chemotherapy Regimens for Triple-Negative Breast Cancer Patients: Development of GRADE (Grades of Recommendation, Assessment, Development and Evaluation) Recommendation by the Italian Association of Medical Oncology (AIOM)

Cancers ◽

10.3390/cancers11081137 ◽

2019 ◽

Vol 11 (8) ◽

pp. 1137 ◽

Cited By ~ 4

Author(s):

Maria Vittoria Dieci ◽

Lucia Del Mastro ◽

Michela Cinquini ◽

Filippo Montemurro ◽

Laura Biganzoli ◽

...

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Febrile Neutropenia ◽

Adverse Events ◽

Triple Negative Breast Cancer ◽

Triple Negative ◽

Medical Oncology ◽

Serious Adverse Events ◽

Assessment Development ◽

Grade 3

In the absence of identified therapeutic targets, chemotherapy is the main systemic treatment option for triple-negative breast cancer (TNBC). The achievement of a pathological complete response (pCR) after neoadjuvant chemotherapy leads to good outcome, whereas patients not achieving a pCR are at high risk of relapse. Various trials have evaluated the inclusion of platinum in neoadjuvant chemotherapy regimens for TNBC, leading to non-univocal results. The panel of the Italian Association of Medical Oncology (AIOM) Guidelines on Breast Cancer developed a clinical recommendation on the addition of platinum to anthracycline/taxane-based neoadjuvant chemotherapy for TNBC by using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology and the Evidence to Decision framework (EtD). Five studies were eligible. The panel identified the following outcomes of benefit: pCR (critical), disease/event-free survival (DFS/EFS, critical), and overall survival (OS, critical). The panel identified febrile neutropenia (critical), serious adverse events (critical), anemia grade 3–4 (important), thrombocytopenia grade 3–4 (important) as outcomes of harms. The probability of pCR was higher in the platinum-based chemotherapy group versus control group (RR = 1.45, 95%CI 1.28–1.64); however, no impact on long-term outcome was observed. Neoadjuvant treatment regimens containing platinum resulted in a non-significant increase in the risk of febrile neutropenia and in a significant increase in the risk serious adverse events, G3–G4 anemia and G3–G4 thrombocytopenia: 11.3% versus 0.8%, RR = 15.66 (95%CI 6.38–38.44). The panel judged uncertain/favorable the benefit/harms balance. The panel’s final recommendation was conditional in favor of the inclusion of platinum in anthracycline/taxane-based neoadjuvant regimens for TNBC.

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Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor SHR6390 combined with pyrotinib and letrozole in patients with human epidermal growth factor receptor 2-positive (HER2+), hormone receptor positive (HR+) metastatic breast cancer (MBC): Phase Ib study results.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.1035 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 1035-1035

Author(s):

Jian Zhang ◽

Yanchun Meng ◽

Biyun Wang ◽

Leiping Wang ◽

Jun Cao ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast ◽

Maximum Tolerated Dose ◽

Primary Phase ◽

Fixed Dose ◽

Safety And Efficacy ◽

Phase Ib ◽

Her2 Breast Cancer ◽

Study Results ◽

Grade 3

1035 Background: The combining of HER2 targeted therapy and endocrine therapy (ET) has been demonstrated to be a reasonable therapeutic approach and recommended for highly selected patients (pts) with HR+/HER2+ MBC. CDK4/6 inhibitors could sensitize HER2 targeted therapies in multiple patient-derived xenograft models and delay tumor recurrence in a transgenic model of HER2+ breast cancer. The aim of this phase Ib/II study was to investigate the safety and efficacy of adding a CDK 4/6 inhibitor to the combination. Primary phase Ib results were reported. Methods: Patients with HR+/HER2+ MBC who were eligible for first- or second-line treatment were enrolled, and orally received letrozole, pyrotinib, and a novel CDK4/6 inhibitor SHR6390. In the “3+3” dose-exploring phase, letrozole was given at a fixed dose of 2.5mg/d. Pyrotinib and SHR6390 were initially given at a dose of 400mg/d and 125 mg/d respectively (Level I). If the initial dose level could be tolerated, subsequent pts were assigned to the higher level (Level H) with pyrotinib 400 mg/d and SHR6390 150mg/d; otherwise, simultaneously to Level L1 with pyrotinib 400 mg/d, and SHR6390 100 mg/d, or Level L2 with pyrotinib 320mg/d, and SHR6390 125 mg/d. Primary endpoints of phase Ib included dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety and efficacy. Results: As of 4 Jan 2021, a total of 15 pts (Level I 5 pts, Level L1 6 pts, and Level L2 4 pts) were enrolled in phase Ib and received the study treatment. 6 of them had received systemic therapies in the advanced stage, and 10 of them had been previously treated with trastuzumab. The most frequent grade 3/4 adverse events included neutrophil count decreased (n = 6), white blood cell count decreased (n = 4), stomatitis (n = 4) and diarrhea (n = 3). 3 pts (2 in Level I, and 1 in Level L1) had experienced DLTs, all of which were grade 3 stomatitis. Of the 15 pts evaluable for response, 7 pts（46.7%） had achieved confirmed partial responses (1 in Level I, 3 in Level L1, and 3 in Level L2) and 7 pts (46.7%) had stable disease. Based on DLTs and clinical efficacy, pyrotinib 320mg/d, SHR6390 125mg/d, and letrozole 2.5mg/d was declared as RP2D. Conclusions: Data from phase Ib showed the triplet combination of pyrotinib, letrozole, and SHR6390 had an acceptable safety profile and encouraging preliminary efficacy, potentially offering a chemotherapy sparing treatment option for patients with HR+/HER2+ MBC. Enrollment on phase II is ongoing. Clinical trial information: NCT03772353 .

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Clinical significance of brain metastases occurrence in HER2 overexpressing metastatic breast cancer patients treated with trastuzumab

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.10593 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 10593-10593

Author(s):

V. Mari ◽

E. Chamorey ◽

A. Italiano ◽

F. Van Den Bos ◽

R. Ferri-Dessens ◽

...

Keyword(s):

Breast Cancer ◽

Overall Survival ◽

Metastatic Breast Cancer ◽

Cancer Patients ◽

Metastatic Breast ◽

Study Cohort ◽

Breast Cancer Patients ◽

Specific Patient ◽

Study Results ◽

Significant Difference

10593 Background: Recent data report that HER2 overexpressing metastatic breast cancer patients (HER+ MBC pts) treated with trastuzumab (T) have a high rate of Brain metastasis (BM). This study aimed to evaluate the prognostic significance of BM occurrence and the related clinical outcome in a specific patient population. Methods: All the HER+MBC patients treated with trastuzumab (with or without chemotherapy) between 09/1999 and 12/2004 were included in this study. Results: A total of forty three patients were enrolled into the study cohort. The median follow-up was 48 months (range, 11–166). Fifteen patients (35%) developped BM. The median interval from the the first MBC event to BM was 18 months (range, 1–65). In multivariate analysis; younger age was the only factor associated with BM occurrence (46 versus 57 years; p = 0.01). Patients with BM tend to have a longer median duration of response to T than patients without BM (16 months versus 13 months; p = 0.1). At the time of BM appearance, 6 of the 15 patients (40%) were still responding or had achieved extracranial stable disease while receiving trastuzumab. Twelve out of 15 (80%) pts received a whole-brain radiation therapy, and 8 pts continued to receive trastuzumab until extracranial disease progression. The median overall survival for patients diagnosed with BM was 10 months (range, 2–42). At three-year, there was no significant difference in overall survival rates between the two groups. The 3-YS was 63.5% and 66.7% for pts with or without BM, respectively; (p = 0.7). Conclusions: The BM occurrence in HER2+ MBC pts treated with Trastuzumab is not linked to tumour resistance, but likely related to the T inability to cross the blood-brain barrier. There is no impaired survival for these pts treated with effective and appropriate therapy. [Table: see text]

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Feasibility and toxicity of docetaxel before or after fluorouracil, epirubicin, and cyclophosphamide as adjuvant chemotherapy for early-stage breast cancer

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.604 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 604-604

Author(s):

H. Abe ◽

T. Umeda ◽

Y. Kawai ◽

M. Tanaka ◽

T. Shimizu ◽

...

Keyword(s):

Breast Cancer ◽

Adjuvant Chemotherapy ◽

Febrile Neutropenia ◽

Adverse Events ◽

Early Stage ◽

Dose Intensity ◽

Completion Rate ◽

Early Stage Breast Cancer ◽

Hematological Toxicity ◽

Grade 3

604 Background: As adjuvant chemotherapy for breast cancer, the addition of docetaxel to regimens containing anthracyline has been shown to be effective. However, tolerance and safety associated with the administration order of the two drugs have not been evaluated. Methods: Breast cancer patients with node-positive or high-risk patients with node-negative were eligible. The treatment completion rate and toxicity were evaluated in 2 arms who underwent a total of 6 courses of the following regimens: Arm A: 3 courses of fluorouracil 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2 (FEC100: q3w) followed by 3 courses of docetaxel (DOC100: 100 mg/m2, q3w); and Arm B: 3 courses of DOC100 (q3w) followed by 3 courses of FEC100 (q3w). Results: June 2006 to April 2008, 42 patients were registered. To the present, analysis has been completed in 21 patients in arm A and 21 in arm B. The mean age of patients was 49.1 years and 53.8 years, respectively. In arm A, the stage of cancer was 1 in 4 patients, 2a in 10, and 2b in 7, in arm B, the stage of cancer was 1 in 3 patients, 2a in 9, and 2b in 9. The adjuvant chemotherapy completion rate was 100 % for arm A and 95.2 % for arm B. The relative dose intensity (RDI) was 94.2 % for FEC100 and 97.8 % for DOC100 in arm A, and 98.9 % for DOC100 and 95.2 % for FEC100 in arm B. In arm A, grade 3 or higher hematological toxicity was observed in 9 patients, and febrile neutropenia developed in 3 patients with FEC100. In arm B, grade 3 or higher hematological toxicity was observed in 7 patients, but febrile neutropenia was not noted in any patients. Grade 3 or higher non-hematological toxicity was observed with FEC100 in 2 patients each in the two arms. Grade 1 or 2 edema developed in 11 patients with DOC100 in the two arms. Conclusions: In both arm A and B, adverse events associated with FEC100 were frequently observed but spontaneously recovered, or adequate management was possible by supportive therapy. Adverse events associated with DOC100 were mild. The regimens in both arms A and B were safe regarding adjuvant chemotherapy for early stage breast cancer. However, DOC100 followed by FEC100 may be more tolerable and effective. No significant financial relationships to disclose.

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