A multicenter randomized phase II trial of granulocyte-colony stimulating factor-supported, platinum-based chemotherapy with flexible midcycle cisplatin administration in patients with advanced ovarian carcinoma

Abstract

BACKGROUND The purpose of this study was to analyze whether the addition of granulocyte‐colony stimulating factor (G‐CSF) to platinum‐based combination chemotherapy could increase platinum dose intensity and response rates and decrease hematologic toxicity in patients with advanced epithelial ovarian carcinoma. METHODS Patients with untreated advanced ovarian carcinoma (International Federation of Gynecology and Obstetrics [FIGO] Stage IIC‐IV) were treated after maximum debulking surgery with cyclophosphamide, 750 mg/m2, and carboplatin, 350 mg/m2, on Day 1 plus cisplatin, 75 mg/m2, on Day 14 when clinically indicated (adequate bone marrow and renal function). Patients were randomized to receive chemotherapy alone (Arm A) or chemotherapy supported with G‐CSF (5 μg/kg subcutaneously on Days 2‐13; Arm B). RESULTS Between November 1993 and April 1995, 80 patients were included. Seventy‐eight patients were evaluable for dose intensity calculations. Both groups were well matched with regard to age, Eastern Cooperative Oncology Group performance status, histopathologic subtype, tumor grade, FIGO stage, and residual tumor after surgery. The dose intensities calculated in mg/m2/week for cyclophosphamide and carboplatin were similar in both groups; however, the dose intensity of cisplatin was higher in Arm B (5.7 mg/m2 vs. 10.3 mg/m2). The occurrence of Common Toxicity Criteria Grade 3‐4 neutropenia was less common in the G‐CSF arm (55% vs. 7.7%). Response rates (52% vs. 68%) and pathologic complete responses (32% vs. 25%) were similar in both groups. CONCLUSIONS The addition of G‐CSF to this platinum‐based chemotherapy regimen in patients with advanced ovarian carcinoma resulted in a modest increment in platinum dose intensity and appeared to reduce the incidence of Grade 3‐4 neutropenia. Cancer 1998;83:719‐725. © 1998 American Cancer Society.

Effect of primary prophylactic G-CSF use on systemic therapy administration for elderly breast cancer patients

“…Previous clinical trials and other studies found that primary prophylactic G-CSF administration increased adherence to preplanned chemotherapy regimens, improved administration of adequate chemotherapy dose intensity, and facilitated the ability to increase the dose intensity when medically indicated [10,17,29,[52][53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70]. This study is the first to look at the effect of primary prophylactic G-CSF on chemotherapy administration using a national sample of elderly women with breast cancer.…”

Impact of Hematopoietic Growth Factors on Blood Transfusion Needs, Incidence of Neutropenia, and Overall Survival Among Elderly Advanced Ovarian Cancer Patients Treated With Chemotherapy

“…Clinical trials in ovarian cancer have similarly reported a reduction in the incidence of neutropenia as well as greater feasibility of chemotherapy dose escalation in patients receiving CSFs. 28,29 A meta-analysis that included 59 randomized trials and more than 25,000 patients found lower all-cause mortality in patients receiving chemotherapy and CSF support. 10 Despite this growing body of literature, evidence in the elderly cancer population is limited.…”

Primary prophylaxis of bacterial infections and Pneumocystis jirovecii pneumonia in patients with hematologic malignancies and solid tumors: 2020 updated guidelines of the Infectious Diseases Working Party of the German Society of Hematology and Medical Oncology (AGIHO/DGHO)

“…The incidence of febrile neutropenia is highly variable depending on patient-related risk factors as well as type of treatment and ranges from close to 0% (low-intensity treatment for solid tumors) [ 7 ] to almost 100% (induction treatment for acute leukemia) [ 8 ]. Real-life incidence rates may in general be higher outside the controlled conditions of prospective clinical trials [ 9 ].…”