Prospective long-term follow-up after first-line subcutaneous cladribine in hairy cell leukemia: a SAKK trial

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Prospective long-term follow-up after first-line subcutaneous cladribine in hairy cell leukemia: a SAKK trial

BENZ, Rudolf, et al.

Abstract

Hairy cell leukemia (HCL) remains an incurable disease. However, first-line treatment with either intravenous or subcutaneous cladribine generally leads to long-lasting remissions.

Although there are excellent long-term data for intravenous application, similar data regarding subcutaneous administration are lacking. We therefore analyzed the long-term outcome of 3 prospective multicenter clinical trials on subcutaneous cladribine performed by the Swiss Group for Clinical Cancer Research (SAKK), which recruited 221 patients with classical HCL between 1993 and 2005. Median overall survival from start of treatment was not reached.

Pretreatment anemia, higher Eastern Cooperative Oncology Group score, and higher age were associated with poorer overall survival in multivariable analysis, whereas early progression at 24 and 36 months had no significant impact on overall survival. Second-line treatment was necessary in 53 (23.7%) patients after a median of 5 (range, 0.2-20.4) years, and first retreatment was mainly monotherapy with cladribine (66%) or rituximab (15.1%) or a combination of these drugs (15.1%). A total of 44 [...]

BENZ, Rudolf, et al . Prospective long-term follow-up after first-line subcutaneous cladribine in hairy cell leukemia: a SAKK trial. Blood Advances , 2020, vol. 4, no. 15, p. 3699-3707

DOI : 10.1182/bloodadvances.2020002160 PMID : 32777066

Available at:

http://archive-ouverte.unige.ch/unige:143935

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Supplemental files

Table: Early toxicity in different studies

First author Pooled

Data SAKK

von Rohr¹⁵ Cheson³⁵ Jehn¹¹ Hoffman³⁶ Grever²⁹

Drug; iv/sc Cld sc Cld sc Cld iv Cld iv Cld iv 2CDF iv

nausea/vomiting only GI/II

(no vomiting)

14/4/0.5/0.3 12/7/0/0 -/-/18/0

constipation/diarrhea only G I/II 5/1/0/0.1 4/12/0/0 -/-/2/0 hemorrhage 46/5/0/1 -/-/-/1 2/2/0.6/0.6

fever 14/20/0/2 GIII/IV 47% -/-/2/0

infection 18/9/6/6 29/9/12

(GIII/IV) 1/13/13/3 5/5/0/0

pneumonia 3/2//0.7/0.7

skin reaction only GI/II 8/5/4/0.5 7/7/0/0 -/-/4/0

neurologic (incl.

headache) 1 GIII 18/6/1/0.1 12/9/0/0 -/-/1/0

other 80/12/6/3 1 GIII 15/8/7/2

drug related death

0 0 10 0 0 3 early

deaths Early toxicity according to WHO grading as reported in several studies. (Clb: cladribine, 2CDF:

pentostatin, sc.: subcutaneous, iv.: intravenous)