Number of Patients Screened | 18 |
Number of Patients Enrolled | 17 |
Number of Patients Evaluable for Toxicity | 17 |
Number of Patients Evaluated for Efficacy | 14 |
Evaluation Method | Other (toxicity: CTCAE version 3; efficacy: MacDonald criteria) |
Response Assessment CR | n = 3 (21.4%) |
Response Assessment PR | n = 5 (35.7%) |
Response Assessment SD | n = 2 (14.3%) |
Response Assessment PD | n = 4 (28.6%) |
Response Assessment OTHER | n = 0 (0%) |
(Median) Duration Assessments PFS | 4.2 months |
(Median) Duration Assessments OS | 44.5 months |
Outcome Notes |
Treatment response was assessed by MRI of the brain every 4 weeks. Patients remained on treatment until complete response was achieved, or after completion of a maximum of eight cycles. Response assessment was defined using modified MacDonald criteria on brain MRI, as follows: • Complete response (CR): absence of gadolinium enhancing tumor on MRI or clearance/absence of malignant cells in cerebrospinal fluid. • Partial response (PR): 50% or more decrease in gadolinium enhancing tumor on MRI on cross‐sectional dimensions but not qualifying for complete response. • Stable disease (SD): does not qualify for complete response, partial response, or progression. • Progressive disease (PD): 25% or more increase in gadolinium enhancing tumor on MRI on cross‐sectional dimensions lesion. The response was assessed at the end of the treatment for each patient. Among all 17 patients, 14 patients were evaluable for response assessment: 3 patients achieved a CR, 5 patients had a PR, 2 patients had SD, and 4 patients had PD (Table 1, Fig. 1). CR was seen after two and eight cycles of pemetrexed in two patients at 1,200 mg/m2 and after eight cycles in one patient at 900 mg/m2. An additional patient achieved CR as the best response after two cycles at a dose level of 1,200 mg/m2; however, this patient ultimately progressed after two more cycles. The ORR including CR + PR was 57.1%, and the DCR including PR + CR + SD was 71.4%. The 6‐month PFS and 12‐month PFS were 35.7% (95% confidence interval [CI], 18%–72%) and 21.4% (95% CI, 8%–58%), respectively, with a median PFS of 4.2 months (95% CI, 2 months, not reached [NR]). The median OS was 44.5 months (95% CI, 19 months, NR). The estimated 1‐year, 2‐year, and 5‐year survival rates were 78.6%, 64.3%, and 35.7%, respectively. In the ITT analysis (17 patients), the DCR and ORR were 58.8% and 47.1%, respectively, with a median OS at 30 months (95% CI, 17 months, NR; Figs. 2, 3). Reason for study discontinuation was completion of treatment in five patients, PD in four patients, toxicity in five patients, medical decision in two patients, death for one patient, and withdrawal of consent for one patient. |