Platinum plus pemetrexed, followed by best supportive care, with or without maintenance gemcitabine

A randomized, open-label, phase II clinical trial (NVALT19 [Netherlands Trial Registry ID NTR4132/NL3847]) included 130 patients with unresectable malignant mesothelioma and no evidence of disease progression after at least four cycles of first-line chemotherapy with platinum plus pemetrexed. Patients were randomly assigned (1:1) to receive either maintenance IV gemcitabine (1,250 mg/m2 on days 1 and 8 of 21-day cycles) plus supportive care (n = 65), or to receive best supportive care alone (n = 65). Patients received treatment until disease progression, unacceptable toxicity, serious intercurrent illness, need for other anticancer therapy (except for palliative radiotherapy), or patient request for discontinuation. The primary end point was PFS in the intention-to-treat population.[6]The study demonstrated delayed disease progression in patients receiving maintenance gemcitabine, but the effect on OS is unclear.

A randomized, open-label, phase II clinical trial (NVALT19 [Netherlands Trial Registry ID NTR4132/NL3847]) included 130 patients with unresectable malignant mesothelioma and no evidence of disease progression after at least four cycles of first-line chemotherapy with platinum plus pemetrexed. Patients were randomly assigned (1:1) to receive either maintenance IV gemcitabine (1,250 mg/m2 on days 1 and 8 of 21-day cycles) plus supportive care (n = 65), or to receive best supportive care alone (n = 65). Patients received treatment until disease progression, unacceptable toxicity, serious intercurrent illness, need for other anticancer therapy (except for palliative radiotherapy), or patient request for discontinuation. The primary end point was PFS in the intention-to-treat population.[6]The study demonstrated delayed disease progression in patients receiving maintenance gemcitabine, but the effect on OS is unclear.

After a median follow-up of 36.5 months, the median PFS was 6.2 months in the gemcitabine group (95% CI, 4.6–8.7) and 3.2 months (95% CI, 2.8–4.1) in the supportive-care group (HR, 0.48; 95% CI, 0.33–0.71; P = .0002). The PFS benefit was confirmed by masked independent central review (HR, 0.49; 95% CI, 0.33–0.72; P = .0002).[6][Level of evidence B1]

A randomized, open-label, phase II clinical trial (NVALT19 [Netherlands Trial Registry ID NTR4132/NL3847]) included 130 patients with unresectable malignant mesothelioma and no evidence of disease progression after at least four cycles of first-line chemotherapy with platinum plus pemetrexed. Patients were randomly assigned (1:1) to receive either maintenance IV gemcitabine (1,250 mg/m2 on days 1 and 8 of 21-day cycles) plus supportive care (n = 65), or to receive best supportive care alone (n = 65). Patients received treatment until disease progression, unacceptable toxicity, serious intercurrent illness, need for other anticancer therapy (except for palliative radiotherapy), or patient request for discontinuation. The primary end point was PFS in the intention-to-treat population.[6]The study demonstrated delayed disease progression in patients receiving maintenance gemcitabine, but the effect on OS is unclear.

Among patients with measurable disease at baseline, the objective radiological response rate was 17% in the gemcitabine group and 4% in the supportive-care group (P = .048).

A randomized, open-label, phase II clinical trial (NVALT19 [Netherlands Trial Registry ID NTR4132/NL3847]) included 130 patients with unresectable malignant mesothelioma and no evidence of disease progression after at least four cycles of first-line chemotherapy with platinum plus pemetrexed. Patients were randomly assigned (1:1) to receive either maintenance IV gemcitabine (1,250 mg/m2 on days 1 and 8 of 21-day cycles) plus supportive care (n = 65), or to receive best supportive care alone (n = 65). Patients received treatment until disease progression, unacceptable toxicity, serious intercurrent illness, need for other anticancer therapy (except for palliative radiotherapy), or patient request for discontinuation. The primary end point was PFS in the intention-to-treat population.[6]The study demonstrated delayed disease progression in patients receiving maintenance gemcitabine, but the effect on OS is unclear.

The median OS was 16.4 months (95% CI, 11.6–20.2) in the gemcitabine group and 13.4 months (95% CI, 12.4–17.8) in the supportive care group (HR, 0.90; 95% CI, 0.60–1.34; P = .60).

A randomized, open-label, phase II clinical trial (NVALT19 [Netherlands Trial Registry ID NTR4132/NL3847]) included 130 patients with unresectable malignant mesothelioma and no evidence of disease progression after at least four cycles of first-line chemotherapy with platinum plus pemetrexed. Patients were randomly assigned (1:1) to receive either maintenance IV gemcitabine (1,250 mg/m2 on days 1 and 8 of 21-day cycles) plus supportive care (n = 65), or to receive best supportive care alone (n = 65). Patients received treatment until disease progression, unacceptable toxicity, serious intercurrent illness, need for other anticancer therapy (except for palliative radiotherapy), or patient request for discontinuation. The primary end point was PFS in the intention-to-treat population.[6]The study demonstrated delayed disease progression in patients receiving maintenance gemcitabine, but the effect on OS is unclear.

Grade 3 or higher treatment-related adverse events occurred in 52% of patients in the gemcitabine group and 16% of patients in the supportive-care group. One patient in the gemcitabine group died of a treatment-related serious adverse event (grade 5 infection).