Table 1 Patient characteristics and... | American Society of Hematology

Table 1

Patient characteristics and clinical presentation of PCP

		Pre-ibrutinib			Pre-PCP*			Presentation and diagnosis of PCP	Treatment and outcome
Patient Age/Sex	Rai stage FISH, IGHV	ALC/μL ANC/μL	CD4/μL CD8/μL CD19/μL NK/μL	IgG mg/dL IgM mg/dL IgA mg/dL	ALC/μL ANC/μL	CD4/μL CD8/μL CD19/μL NK/μL	IgG mg/dL IgM mg/dL IgA mg/dL	Presentation and diagnosis of PCP	Treatment and outcome
PCP#1 69/M	II Del17p, IGHV-M	39 830	1593	500	135 940	N/A†	N/A†	TT-PCP: 1.9 mo;	TMP/SMX 2DS thrice daily, then twice daily for a total of 21 d;
		2140	876	18	2920			CT: multifocal infiltrates (Figure 1B);	Resolved, on prophylaxis (Figure 1C)
			36 763	47				BAL: PCR+, DFA−, no other pathogen
			239	47				BAL: PCR+, DFA−, no other pathogen
PCP#2 68/M	I Tri12, IGHV-U	5820	639	487	1810	551	727‡	TT-PCP: 23.6 mo;	TMP/SMX 2DS thrice daily, then switched to atovaquone 750 mg twice daily for a total of 21 d;
		4420	267	6	4820	201	6	CT: focal infiltrates;	Resolved, no prophylaxis
			5108	33		6	31	BAL: PCR+, DFA−, coexisting Mycobacterium gordonae
			182	33		146	31	BAL: PCR+, DFA−, coexisting Mycobacterium gordonae
PCP#3 72/M	III Normal, IGHV-U	90 830	1362	1013	115 690	N/A†	N/A†	TT-PCP: 1.9 mo;	TMP/SMX 2DS twice daily for 18 d;
		1870	1181	86	1060			CT: bilateral infiltrates;	Resolved, on prophylaxis
			88 014	127				BAL: PCR+, DFA−, no other pathogen
			91	127				BAL: PCR+, DFA−, no other pathogen
PCP#4 78M§	IV Tri12, IGHV-U	184 524	2074	935	79 310	966	809	TT-PCP: 6.0 mo;	TMP/SMX 2DS thrice daily for 14 d;
		12 870	2860	27	5650	1277	84	CT: bilateral infiltrates;	Resolved, no prophylaxis
			177 800	211		61 825	185	BAL: PCR+, DFA+; coexisting S aureus and rhino/enterovirus
			1790	211		1473	185
PCP#5 70/M	III Tri12, IGHV-U	191 310	2704	514	1470	734	615	TT-PCP: 11.6 mo;	TMP/SMX 2DS thrice daily for 21 d;
		1970	1341	54	4760	350	97	CT: nodular infiltrates (Figure 1D);	Resolved, electively began prophylaxis a year after PCP (Figure 1E)
			164 597	49		69	126	BAL: PCR+, DFA−, coexisting Penicillium
			938	49		106	126	BAL: PCR+, DFA−, coexisting Penicillium

		Pre-ibrutinib			Pre-PCP*			Presentation and diagnosis of PCP	Treatment and outcome
Patient Age/Sex	Rai stage FISH, IGHV	ALC/μL ANC/μL	CD4/μL CD8/μL CD19/μL NK/μL	IgG mg/dL IgM mg/dL IgA mg/dL	ALC/μL ANC/μL	CD4/μL CD8/μL CD19/μL NK/μL	IgG mg/dL IgM mg/dL IgA mg/dL	Presentation and diagnosis of PCP	Treatment and outcome
PCP#1 69/M	II Del17p, IGHV-M	39 830	1593	500	135 940	N/A†	N/A†	TT-PCP: 1.9 mo;	TMP/SMX 2DS thrice daily, then twice daily for a total of 21 d;
		2140	876	18	2920			CT: multifocal infiltrates (Figure 1B);	Resolved, on prophylaxis (Figure 1C)
			36 763	47				BAL: PCR+, DFA−, no other pathogen
			239	47				BAL: PCR+, DFA−, no other pathogen
PCP#2 68/M	I Tri12, IGHV-U	5820	639	487	1810	551	727‡	TT-PCP: 23.6 mo;	TMP/SMX 2DS thrice daily, then switched to atovaquone 750 mg twice daily for a total of 21 d;
		4420	267	6	4820	201	6	CT: focal infiltrates;	Resolved, no prophylaxis
			5108	33		6	31	BAL: PCR+, DFA−, coexisting Mycobacterium gordonae
			182	33		146	31	BAL: PCR+, DFA−, coexisting Mycobacterium gordonae
PCP#3 72/M	III Normal, IGHV-U	90 830	1362	1013	115 690	N/A†	N/A†	TT-PCP: 1.9 mo;	TMP/SMX 2DS twice daily for 18 d;
		1870	1181	86	1060			CT: bilateral infiltrates;	Resolved, on prophylaxis
			88 014	127				BAL: PCR+, DFA−, no other pathogen
			91	127				BAL: PCR+, DFA−, no other pathogen
PCP#4 78M§	IV Tri12, IGHV-U	184 524	2074	935	79 310	966	809	TT-PCP: 6.0 mo;	TMP/SMX 2DS thrice daily for 14 d;
		12 870	2860	27	5650	1277	84	CT: bilateral infiltrates;	Resolved, no prophylaxis
			177 800	211		61 825	185	BAL: PCR+, DFA+; coexisting S aureus and rhino/enterovirus
			1790	211		1473	185
PCP#5 70/M	III Tri12, IGHV-U	191 310	2704	514	1470	734	615	TT-PCP: 11.6 mo;	TMP/SMX 2DS thrice daily for 21 d;
		1970	1341	54	4760	350	97	CT: nodular infiltrates (Figure 1D);	Resolved, electively began prophylaxis a year after PCP (Figure 1E)
			164 597	49		69	126	BAL: PCR+, DFA−, coexisting Penicillium
			938	49		106	126	BAL: PCR+, DFA−, coexisting Penicillium

All patients, except for PCP#4 received ibrutinib as first-line therapy.

ALC, absolute lymphocyte count; ANC, absolute neutrophil count; CD4, absolute CD4⁺ T-cell count; FISH, fluorescence in situ hybridization (Del17p: deletion 17p, Tri12: trisomy 12); IgG, immunoglobulin G; IGHV, Ig heavy chain variable (M: mutated, U: unmutated); NK, natural killer; S aureus, Staphylococcus aureus; TMP/SMX, trimethoprim/sulfamethoxazole; TT-PCP, time from the start of ibrutinib until the first diagnosis of PCP.

ALC and ANC were assessed within 1 week prior to PCP diagnosis. Lymphocyte and Ig subsets were assessed within 2 weeks prior to PCP diagnosis.

†

No lymphocytes subset or Ig data are available between starting ibrutinib and PCP diagnosis for the 2 patients diagnosed at 2 months on single-agent ibritinib.

‡

Patient was receiving IVIG replacement.

Patient was previously treated with two lines of therapy prior to ibrutinib. All other patients were previously untreated for CLL prior to ibrutinib.

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