Phase II Trial of Weekly Paclitaxel in Previously Untreated Advanced Non-Small-Cell Lung Cancer

Abstract

Objective: New effective therapy is desirable for outpatients with advanced non-small-cell lung cancer (NSCLC). Fractionated administration of paclitaxel may be less toxic and more active against NSCLC. The aim of this study was to evaluate the activity and toxicity of weekly paclitaxel therapy for chemotherapy-naive NSCLC. Methods: Patients with pathological or cytological diagnosis of NSCLC, measurable lesions, and no prior therapy were enrolled. We administered weekly infusions of 80 mg/m² paclitaxel 3 times in a 4-week cycle. In the absence of progressive disease or intolerable toxicity, we treated each patient for a minimum of four cycles. Results: Of 35 patients enrolled, 17 patients achieved partial response, although no complete responses were observed (response rate 49%; 95% confidence interval 32–66%). The median survival time was 55 weeks (range 6–93 weeks). Grade 3 or 4 leukopenia occurred in only 1 patient (3%). Neurotoxicity was the most frequent adverse effect (grades 1 and 2, 26 and 3%, respectively). Serious toxicity, observed in 2 patients (6%), was interstitial pneumonia, and 1 patient died from sequela. Conclusion: Low-dose weekly paclitaxel is a promising therapy for advanced NSCLC with high effectiveness and low toxicity.

Interstitielle Lungenerkrankung nach Monotherapie mit an Albumin-Nanopartikel gebundenem Paclitaxel bei Patienten mit fortgeschrittenem nicht-kleinzelligem Bronchialkarzinom

“…Angesichts einer ILD-Inzidenz bei mit PTX behandelten Patienten von rund 1% [4,5] gilt das mit diesem Arzneimittel assoziierte ILD-Risiko als gering. Nab-PTX ist eine neue, lösungsmittelfreie PTX-Formulierung, die in Kombination mit Carboplatin signifikante Wirksamkeit im Hinblick auf die Verbesserung der Prognose bei abgemildertem Toxizitätsprofil zeigt.…”

“…In der Erstlinientherapie des fortgeschrittenen nicht-kleinzelligen Bronchialkarzinoms (non-small cell lung cancer, NSCLC) hat nab-PTX in Kombination mit anderen, platinhaltigen Verbindungen signifikante Wirksamkeit im Hinblick auf eine bessere Prognose der Patienten und mildere Toxizitätsprofile gezeigt [1,2,3]. Eine durch PTX induzierte interstitielle Lungenerkrankung (ILD) tritt bei etwa 1% der behandelten Patienten auf [4,5]; damit gilt PTX in Bezug auf das Risiko für arzneimittelinduzierte ILD als relativ sicher. Die Inzidenz der nab-PTX-induzierten ILD ist zwar nicht bekannt, man geht jedoch davon aus, dass diese Formulierung mit einem vergleichbaren ILD-Risiko verbunden ist wie PTX.…”

Weekly Paclitaxel Combined with Carboplatin Versus the Standard Every 3-Weeks Paclitaxel and Carboplatin for Elderly Patients with Previously Untreated Advanced Non-Small Cell Lung Cancer.

“…Rossi et al 22 reported response rate of 37.5% with weekly paclitaxel in elderly patients with advanced NSCLC. However, weekly paclitaxel in elderly patients with advanced NSCLC in Fidias et al 23 study had an overall response rate of 23%, median time to failure of 5.2 months, median survival time of 10.3 months and survival rates after 1 and 2 years of 45% and 22%, respectively, and in Yasuda et al 24 study had an overall response rate of 49% and median survival time of 55 weeks.…”

Paclitaxel-induced Interstitial Pneumonia after Drug-eluting Stent Implantation: Report of a Fatal Case

“…Paclitaxel-induced interstitial pneumonia occurs in approximately 1% of treated patients (5,6). Although many of these side effects appear to be schedule and dose dependant (7,8), several reports have indicated that pulmonary toxicity is not in this category, and that paclitaxel may trigger pulmonary allergic responses (8)(9)(10)(11) (6,(12)(13)(14)(15) …”