Pulmonary Toxicity in Patients With Advanced-Stage Germ Cell Tumors Receiving Bleomycin With and Without Granulocyte Colony Stimulating Factor

e17056 Background: Testicular germ cell tumors (GCTs) represent only one percent of all solid tumors; however, they are the most common solid malignancy in men 15-35 years old. Febrile neutropenia (FN) is a grievous complication of chemotherapy, frequently occurring in GCT patients. The aim of this retrospective study was to assess the effect of primary granulocyte-colony stimulating factor (G-CSF) prophylaxis on the incidence of FN in GCT patients. Methods: This study was conducted using the National Cancer Institute medical records database. Patients diagnosed with germ cell tumors treated with first line/adjuvant chemotherapy at the National Cancer Institute, Bratislava, Slovakia from January 2000 to December 2017 were eligible. Starting in January 2006, patients received G-CSF prophylaxis after every cycle of chemotherapy. Results: Out of 393 patients, 265 patients received primary G-CSF prophylaxis and 128 patients did not receive prophylaxis. The majority of patients (69.97%) were treated with bleomycin, etoposide and cisplatin chemotherapy. There were 61 deaths (15.5%) in our study population. 2- and 5-year OS of the study group was 86.8% and 83.1%, respectively. During the study period, 71 patients (18.1%) suffered FN events. Out of 128 patients who did not receive primary prophylaxis, 42 (32.8%) patients suffered FN, while only 29 (10.9%) patients with primary prophylaxis suffered FN ( P = 0.0000001). On subgroup analysis, FN incidence decreased in all groups with primary prophylaxis, except for patients with stage I GCT receiving adjuvant chemotherapy. Patients receiving G-CSF prophylaxis had significantly longer overall survival when compared to patients without prophylaxis. (HR = 0.44, 95% CI 0.26-0.75; P = 0.0009). Conclusions: Primary G-CSF prophylaxis was associated with significantly decreased FN incidence and longer overall survival in patients treated with first line chemotherapy and should be consider in all patients except stage I disease.

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Analysis of the Safety of Pegfilgrastim Addition in Bleomycin, Etoposide, and Cisplatin Treatment Patients With Germ Cell Tumors

Frontiers in Oncology ◽

10.3389/fonc.2021.770067 ◽

2022 ◽

Vol 11 ◽

Author(s):

Ryunosuke Nakagawa ◽

Hiroaki Iwamoto ◽

Tomoyuki Makino ◽

Suguru Kadomoto ◽

Hiroshi Yaegashi ◽

...

Keyword(s):

Retrospective Study ◽

Germ Cell ◽

Germ Cell Tumors ◽

Granulocyte Colony Stimulating Factor ◽

Colony Stimulating Factor ◽

Single Center ◽

Chemotherapy Drugs ◽

Significant Difference ◽

Grade 3 ◽

Stimulating Factor

It has been reported that chemotherapy drugs and granulocyte colony-stimulating factor (G-CSF) administered on the same day can aggravate neutropenia. In the present study, we investigated the safety of pegfilgrastim during bleomycin, etoposide, and cisplatin (BEP) therapy. This single-center retrospective study, including 137 cycles of BEP therapy for germ cell tumors between January 2008 and April 2021, investigated safety. Short-acting G-CSF was used for 84 cycles and pegfilgrastim was used for 53 cycles. In the pegfilgrastim group, neutrophil count at nadir was significantly higher than in the G-CSF group (median 1,650/μl and 680/μl, respectively). The incidence of grade 3–4 neutropenia was significantly higher and the duration longer in the G-CSF group. Also, there was no significant difference in the incidence of febrile neutropenia. In conclusion, concomitant use of pegfilgrastim during BEP therapy did not increase neutropenia and was effective in terms of safety.

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Recommendations for prophylactic granulocyte-colony stimulating factor among advanced stage ovarian cancer patients: Does age over 65 really matter?

Gynecologic Oncology ◽

10.1016/j.ygyno.2018.03.039 ◽

2018 ◽

Vol 149 (3) ◽

pp. 631-632

Author(s):

A.S. Zamorano ◽

J.C. Cripe ◽

M. Dandulakis ◽

S.P. Huepenbecker ◽

R. Schulz ◽

...

Keyword(s):

Ovarian Cancer ◽

Cancer Patients ◽

Advanced Stage ◽

Granulocyte Colony Stimulating Factor ◽

Colony Stimulating Factor ◽

Stimulating Factor

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Randomized trial of r-metHu granulocyte colony-stimulating factor in an intensive treatment for T-cell leukemia and advanced-stage lymphoblastic lymphoma of childhood: a Pediatric Oncology Group pilot study.

Journal of Clinical Oncology ◽

10.1200/jco.1998.16.2.522 ◽

1998 ◽

Vol 16 (2) ◽

pp. 522-526 ◽

Cited By ~ 39

Author(s):

J Laver ◽

M Amylon ◽

S Desai ◽

M Link ◽

M Schwenn ◽

...

Keyword(s):

T Cell ◽

Lymphoblastic Lymphoma ◽

High Dose ◽

Induction Phase ◽

Advanced Stage ◽

Granulocyte Colony Stimulating Factor ◽

Colony Stimulating Factor ◽

Cell Leukemia ◽

Continuation Therapy ◽

Stimulating Factor

PURPOSE Contemporary chemotherapy has significantly improved the event-free survival (EFS) among patients with T-cell disease. However, myelosuppression has been a significant adverse effect of this approach. In this study, we assessed the impact of r-metHu granulocyte colony-stimulating factor (G-CSF) on the period of neutropenia, number of days of hospitalization, and delays in subsequent administration of chemotherapy in a cohort of patients with T-cell leukemia (T-ALL) or advanced stage lymphoblastic lymphoma (ASLL). PATIENTS AND METHODS This open-label, randomized trial incorporated r-metHuG-CSF into the induction and two consecutive continuation-therapy cycles of our intensive program for T-cell malignancies. In the induction phase, r-metHuG-CSF was given after two different combinations of chemotherapy, one of which included vincristine, prednisone, cyclophosphamide, and adriamycin and the other a continuous infusion of high-dose ara-C and L-asparaginase. In the two continuation-therapy cycles, r-metHuG-CSF was given following the combination of vincristine, adriamycin, prednisone, and 6-mercaptopurine (MP) and after continuous infusion of high-dose cytarabine (ara-C). RESULTS Fifty-six patients with T-ALL and 33 with ASLL were enrolled onto study from April 1994 to December 1995. Our data show no significant difference in number of days of absolute neutrophil count (ANC) less than 500/microL, hospitalizations, or delays in therapy in the induction phase. However, in the continuation-therapy phase the number of days of ANC less than 500/microL was significantly shorter (P = .017) on the G-CSF-arm without significantly affecting the number of days of hospitalizations or delays in therapy. CONCLUSION r-metHuG-CSF did not significantly affect the period of neutropenia, hospitalization, or delays in therapy in the induction phase, whereas in the two cycles of continuation therapy, it significantly shortened the period of neutropenia.

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Pulmonary toxicity after granulocyte colony-stimulating factor-combined chemotherapy for non-Hodgkin's lymphoma

British Journal of Cancer ◽

10.1038/bjc.1998.380 ◽

1998 ◽

Vol 77 (12) ◽

pp. 2286-2290 ◽

Cited By ~ 21

Author(s):

N Yokose ◽

K Ogata ◽

H Tamura ◽

E An ◽

K Nakamura ◽

...

Keyword(s):

Pulmonary Toxicity ◽

Hodgkin’S Lymphoma ◽

Hodgkin's Lymphoma ◽

Combined Chemotherapy ◽

Granulocyte Colony Stimulating Factor ◽

Colony Stimulating Factor ◽

Non Hodgkin’S Lymphoma ◽

Non Hodgkin's Lymphoma ◽

Stimulating Factor

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Oxaliplatin and irinotecan plus granulocyte-colony stimulating factor (G-CSF) as third-line treatment in relapsed or cisplatin-refractory germ-cell tumor (GCT) patients: A phase II study

Journal of Clinical Oncology ◽

10.1200/jco.2004.22.14_suppl.4535 ◽

2004 ◽

Vol 22 (14_suppl) ◽

pp. 4535-4535

Author(s):

D. Farmakis ◽

D. Pectasides ◽

M. Pectasides ◽

M. Nikolaou ◽

M. Koumpou ◽

...

Keyword(s):

Germ Cell ◽

Germ Cell Tumor ◽

Phase Ii Study ◽

Cell Tumor ◽

Line Treatment ◽

Granulocyte Colony Stimulating Factor ◽

Colony Stimulating Factor ◽

Third Line ◽

Stimulating Factor ◽

Third Line Treatment

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Unmasking Cryptococcal Meningitis Immune Reconstitution Inflammatory Syndrome due to Granulocyte Colony-Stimulating Factor Use in a Patient with a Poorly Differentiated Germ Cell Neoplasm

Case Reports in Oncology ◽

10.1159/000357666 ◽

2014 ◽

Vol 7 (1) ◽

pp. 1-5 ◽

Cited By ~ 6

Author(s):

Nathan C. Bahr ◽

James Wallace ◽

Anne E.P. Frosch ◽

David R. Boulware

Keyword(s):

Germ Cell ◽

Immune Reconstitution Inflammatory Syndrome ◽

Cryptococcal Meningitis ◽

Immune Reconstitution ◽

Granulocyte Colony Stimulating Factor ◽

Colony Stimulating Factor ◽

Cell Neoplasm ◽

Poorly Differentiated ◽

Inflammatory Syndrome ◽

Stimulating Factor

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Recombinant human granulocyte-macrophage colony-stimulating factor as an adjunct to conventional-dose ifosfamide-based chemotherapy for patients with advanced or relapsed germ cell tumors: a randomized trial.

Journal of Clinical Oncology ◽

10.1200/jco.1995.13.1.79 ◽

1995 ◽

Vol 13 (1) ◽

pp. 79-86 ◽

Cited By ~ 30

Author(s):

D F Bajorin ◽

C R Nichols ◽

H J Schmoll ◽

P W Kantoff ◽

C Bokemeyer ◽

...

Keyword(s):

Growth Factor ◽

Germ Cell ◽

Germ Cell Tumors ◽

Infectious Complications ◽

Colony Stimulating Factor ◽

Routine Administration ◽

Macrophage Colony Stimulating Factor ◽

Macrophage Colony ◽

The Impact ◽

Stimulating Factor

PURPOSE Ifosfamide-containing therapy with cisplatin plus either etoposide (VIP) or vinblastine (VeIP) can cure of patients with relapsed germ cell tumors (GCTs), but results in substantial myelotoxicity. This study sought to assess the impact of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) on the severity of neutropenia and incidence of infectious complications in patients who receive ifosfamide-based chemotherapy for GCT. PATIENTS AND METHODS One hundred and four assessable GCT patients from 20 centers were randomized to receive rhGM-CSF with either cycles 1 and 2 or cycles 3 and 4 of chemotherapy. Standard doses of VIP or VeIP were used. Efficacy data were analyzed using a parallel design for cycles 1 and 2 before the crossover. RESULTS Fewer clinically relevant infections occurred in rhGM-CSF patients (13 of 55, 24%) versus observation patients (22 of 49, 45%) in cycle 1 (P = .01). Decreases were observed in infections during neutropenia (22% v 43%, P = .03), infections requiring intravenous antibiotics (20% v 43%, P = .01), and any infection irrespective of severity (29% v 55%, P = .01) in cycle 1. However, there were no significant differences among the treatment arms in cycle 2 in the proportion of clinically relevant infections (P = .23), infections associated with neutropenia (P = .11), infections requiring antibiotics (P = .22), or any infection (P = .65). rhGM-CSF was discontinued in 14% of cycles because of toxicity related to the growth factor. CONCLUSION rhGM-CSF reduced the incidence of infections in the first cycle of chemotherapy, but no benefit beyond the initial chemotherapy cycle was evident. Based on the limited clinical impact and the high incidence of rhGM-CSF-related toxicity that required growth factor discontinuation, the routine administration of rhGM-CSF to prevent neutropenia and infection after ifosfamide-based chemotherapy for GCT patients is not recommended.

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