Phase i study of 'dose-dense' pemetrexed plus carboplatin/radiotherapy for locally advanced non-small cell lung carcinoma

Table 2 Acute Toxicity

Toxicity	Grade 1-2	Grade 3	Grade 4	Grade 5
*Dose Level #1 (N = 6)**
Neutropenia	1	2	1 ^††	---
Thrombocytopenia	1	1	1 ^††	---
Anemia	3	1	---	---
Esophagitis	3	1	---	---
Pneumonitis	2	1	---	---
Sepsis	--	--	1 ^††	--
Fatigue	4	--	---	---
Elevated LFT's	4	1 ^††	---	---
Elevated Creatinine	1	--	---	---
Worst Toxicity Overall	2	3	1	---
Worst non-heme Toxicity Overall	4	1	1	---
*Dose Level #1A (N = 8)**
Neutropenia	4	3	1	---
Thrombocytopenia	2	1	---	---
Anemia	6	1	---	---
Esophagitis	5	2	---	---
Pneumonitis	3	---	---	1 ^§
Sepsis	---	---	---	---
Fatigue	5	---	1 ^§	---
Elevated LFT's	1	---	---	---
Elevated Creatinine	1	---	---	---
Worst Toxicity Overall	3	3	---	1
Worst non-heme Toxicity Overall	4	1	---	1
				---
Overall Study Population (N = 16) †
Neutropenia	5	5	2	---
Thrombocytopenia	3	2	1 ^††	---
Anemia	9	2	---	---
Esophagitis	8	3	---	---
Pneumonitis	5	1	---	1 ^§
Fatigue	9	0	1	---
Elevated LFT's	5	1	---	---
Elevated Creatinine	2	---	---	---
Worst Toxicity Overall	5	6	1 ^††	1 ^§
Worst non-heme Toxicity Overall	8	2	1 ^††	1 ^§

* Dose Level #1 and Dose Level #1A used the same doses (pemetrexed 300 mg/m2 q2-week); however Dose Level #1 used extended field RT and Dose Level #1A used involved field RT.
† Overall study population included all of the patients treated in Dose Level #1 and Dose Level #1A, as well as two patients who were re-assigned from Dose Level #2 (400 mg/m2) to Dose Level -I (250 mg/m2) because of safety purposes.
†† Single patient with sepsis and multi-organ failure in the setting of acute diverticulitis.
§ Elderly (83-year old) patient with COPD, died from respiratory failure 30 days post-RT.

ISSN: 1748-717X