高齢のNSCLC患者に対しては併用化学療法が有益である

薬物併用により高齢者の進行非小細胞肺がんの生存率が上昇する

Drug combination increases survival in advanced non-small cell lung cancer in the elderly

第46回ASCOのプレナリーセッションで取り上げられたphase IIIスタディの結果、一般的に使用される化学療法剤であるパクリタキセルとカルボプラチンの併用により、標準的な単剤療法と比較し、高齢の非小細胞肺がん（NSCLC）患者の全生存期間および無増悪生存率が有意に上昇したことが示された。このトライアルにおいて研究者らは、進行NSCLC患者（70～89歳）451人において、ゲムシタビンまたはビノレルビンのいずれかを用いた標準的な単剤療法とパクリタキセルとカルボプラチンの併用療法とを比較した。このスタディは中間解析の結果、全生存期間が併用療法（10.4ヵ月）において単剤療法（6.2ヵ月）に比べ長いことが明らかとなった時点で早期に終了となった。また、肺がんが進行するまでの期間が併用療法群において単剤療法群と比べ2倍近いことも明らかにした（6.3ヵ月対3.2ヵ月）。併用療法の毒性は許容範囲内であったが、併用療法群では単剤療法群よりも中等度から重度の好中球減少症を発現する頻度が高かった（47.8%対12.2%）。これらの結果から、高齢患者に対しても若年患者と同様に強化療法を考慮すべきであることが示唆された。

A Phase III randomized, multicenter trial shows that a combination of two commonly used chemotherapy drugs, paclitaxel and carboplatin, significantly increases overall survival and progression-free survival in patients age 70 or older with advanced non-small cell lung cancer (NSCLC) compared to standard single-agent therapy.

"Elderly patients are often not given aggressive treatment out of concern that they will not be able to tolerate it. These results demonstrate that a more intensive regimen given to younger patients can be effective and tolerable in this group," said lead author Elisabeth Quoix, M.D., professor of medicine at University Hospital, in Strasbourg, France.

Few new clinical trials evaluate lung cancer therapies in the elderly, though more than one-half of patients with NSCLC are at least 65, and at least 30 percent of all NSCLC patients are 70 or older. While the standard treatment for elderly patients with advanced lung cancer is single-drug therapy, this recommendation is based on older studies. The combination regimen evaluated in this trial has been proven more effective in another Phase III trial that did not control for age, although a subgroup analysis suggested that this regimen would also be effective in patients 70 or older.

In the current clinical trial, conducted by the French Intergroup of Thoracic Oncology at 62 international centers between 2005 and 2009, Dr. Quoix and her colleagues compared standard single-agent therapy - with either gemcitabine (Gemzar) or vinorelbine (Navelbine) - to combination therapy with paclitaxel and carboplatin in 451 patients with advanced NSCLC between the ages of 70 and 89. The study, which was initially planned to include 520 patients, was stopped early when an interim analysis found that overall survival was longer in the combination group (10.4 months) than in those who received single agent therapy (6.2 months). They also found that patients receiving combination therapy lived nearly twice as long (6.3 months) before their lung cancer progressed as those receiving the single-drug therapy (3.2 months).

While the researchers found the combination therapy had acceptable toxicity, preliminary data in 313 patients found that the group receiving the combination regimen experienced moderate to severe neutropenia more frequently than the single-drug group (47.8 percent vs. 12.2 percent).

Disclosures: Elisabeth Quoix, Consultant or Advisory Role, Lilly, Roche, Honoraria, Lilly, Roche; Jean-Philippe Oster, Stock Ownership, Roche; Virginie Westeel, Honoraria, Lilly, Pierre Fabre Medicament, Other Remuneration, Lilly, Pierre Fabre Medicament, Roche; Eric Pichon, Honoraria, Roche, Other Remuneration, Roche; Gerard Zalcman, Consultant or Advisory Role, Lilly, Roche, Honoraria, Lilly, Roche, Research Funding, Roche; Armelle Lavole, Other Remuneration, Lilly; Marie-Paule Lebitasy, Consultant or Advisory Role, Lilly, Roche, Honoraria, Lilly, Roche, Other Remuneration, Lilly, Roche, Research Funding, Lilly, Roche.