肺がんの維持療法としてのペメトレキセド(Abstract #: 8011)

ペメトレキセドをプラチナ製剤ベースの導入化学療法後の維持療法として使用することにより進行非小細胞肺がんの進行が遅延する
Pemetrexed delays progression of advanced non-small cell lung cancer when used as maintenance therapy after platinum-based induction chemotherapy
プラチナ製剤ベースの導入化学療法完了3~6週後に維持療法としてペメトレキセドを開始することにより進行非小細胞がんの進行が遅延する、とAmerican Society of Clinical Oncology学会で発表された。研究者らはシスプラチンまたはカルボプラチンを含む化学療法を4クール施行後に安定しているstage III BまたはIVの患者441人をペメトレキセドで維持療法を施行する群に無作為に割り付けた。222人の患者はプラセボでの維持療法群に割り付けた。無増悪生存期間はペメトレキセド群においてプラセボ群よりも有意に長かった(4.3ヵ月対2.6ヵ月)。全生存期間はペメトレキセド群で13ヵ月でありプラセボ群では10.2ヵ月であった。筆者らは、ペメトレキセド維持療法の全生存期間に対する効果に関して結論付けるには、最終データの解析が必要であると注意を喚起している。
Full Text

Pemetrexed delays progression of advanced non-small cell lung cancer by 50 percent when started as maintenance therapy three to six weeks after completing four cycles of platinum-based induction chemotherapy, according to a presentation at the annual meeting of the American Society of Clinical Oncology.

?"This is the first study to show that lung cancer patients can benefit from maintenance therapy. The fact that this approach significantly increases the amount of time that patients have before their cancer progresses, without increasing additional side effects, is particularly significant," said lead author Tudor Eliade Ciuleanu, MD, PhD, associate professor at the University of Medicine and Pharmacy Iuliu Hatieganu in Romania.

"We recommend giving pemetrexed after a patient completes initial induction therapy, but before cancer progression occurs. This approach affords the greatest chance of killing stray cancer cells before they have a chance to contribute to tumor growth."

Until the current trial, maintenance chemotherapy had not been proven to be of value for patients with lung cancer and is not a part of the standard of care. Pemetrexed is currently approved by the U.S. Food and Drug Administration for treating disease that has progressed despite previous chemotherapy.

In the current study, researchers analyzed progression-free survival and overall survival among 663 patients with stage IIIB or IV disease that was stable following treatment with a platinum-containing drug such as cisplatin or carboplatin. A total of 441 patients were randomized to pemetrexed; 222 patients received a placebo.

Progression-free survival was significantly longer for pemetrexed (4.3 months) than for placebo (2.6 months). Overall survival was 13 months for pemetrexed compared with 10.2 months for placebo.

However, Ciuleanu cautioned that the findings on overall survival are preliminary, noting that final results will be necessary before researchers are able to draw conclusions about the impact of pemetrexed maintenance therapy on overall survival.

The incidence and severity of side effects were generally similar between the two groups. The most significant side effect was moderate to severe anemia, which occurred in 4.5 percent of the pemetrexed group and 1.4 percent of the placebo group.