Skip to main content
Hauptrubriken
CME Facharzt-Training Webinare Zeitschriften Bücher e.Medpedia Podcast
Service
Jobbörse Info & Hilfe
Fachgebiete
Anästhesiologie Allgemeinmedizin Arbeitsmedizin Augenheilkunde Chirurgie Dermatologie Gynäkologie und Geburtshilfe HNO Innere Medizin Kardiologie Neurologie Onkologie und Hämatologie Orthopädie und Unfallchirurgie Pädiatrie Pathologie Psychiatrie Radiologie Rechtsmedizin Urologie Zahnmedizin
Themen
Typ-2-Diabetes und Adipositas Klimawandel und Gesundheit Neues aus dem Markt Praxis und Beruf Seltene Erkrankungen GOÄ & EBM Panorama
Sammlungen
Kasuistiken Algorithmen & Infografiken Blickdiagnosen Arthropedia FlapFinder (für Dermatochirurgen) Videos Kongressberichterstattung Medizin für Apothekerinnen und Apotheker Fachpsychotherapie Für Ärztinnen und Ärzte in Weiterbildung Für Medizinstudierende Patientenratgeber
Erweiterte Suche
Anmelden
nach oben
Investigational New Drugs
Erschienen in:

02.05.2017 | PHASE I STUDIES

Phase I study of Nedaplatin, a platinum based antineoplastic drug, combined with nab-paclitaxel in patients with advanced squamous non–small cell lung cancer

verfasst von: Satoshi Igawa, Sakiko Otani, Yoshiro Nakahara, Shinichiro Ryuge, Yasuhiro Hiyoshi, Tomoya Fukui, Hisashi Mitsufuji, Masaru Kubota, Masato Katagiri, Yuichi Sato, Jiichiro Sasaki, Noriyuki Masuda

Erschienen in: Investigational New Drugs | Ausgabe 1/2018

Einloggen, um Zugang zu erhalten

Summary

Background This study was designed to determine the recommended dose of a combination of nedaplatin (NED) and nab-paclitaxel (nab-PTX) in chemotherapy-naive patients with advanced squamous non-small-cell lung cancer (NSCLC). Methods Patients received escalating doses of NED on day 1 and nab-PTX on days 1, 8, and 15 every 4 weeks by an intravenous infusion for up to six cycles. Results A dose of 100 mg/m2 NED and 100 mg/m2 nab-PTX was determined to be the recommended dose for patients with advanced squamous NSCLC. The study had an overall response rate of 66.7% (95% confidence interval [CI]: 38.4–88.2) and disease control rate of 93.3% (95% CI: 68.1–99.8). The median progression-free survival time and survival time was 7.0 months (95% CI: 5.9–8.1) and 13.1 months (95% CI: 6.2–20.1), respectively. The most common adverse events were neutropenia (grade 3/4, 33%) and leukopenia (grade 3/4, 27%). Although peripheral neuropathy was observed in 5 patients (grade 1/2), non-hematological toxic effects were relatively mild. Febrile neutropenia, pneumonitis, and treatment-related death were not observed. Conclusions The combination of NED and nab-PTX was a tolerable and effective regimen and its recommended dose was 100 mg/m2 and 100 mg/m2, respectively, in chemotherapy-naive patients with advanced squamous NSCLC (UMIN000010963).
Literatur
1.
Devesa SS, Bray F, Vizcaino AP, Parkin DM (2005) International lung cancer trends by histologic type: male:female differences diminishing and adenocarcinoma rates rising. Int J Cancer 117(2):294–299. doi:10.​1002/​ijc.​21183 CrossRefPubMed
2.
Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH (2002) Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346(2):92–98. doi:10.​1056/​NEJMoa011954 CrossRefPubMed
3.
Kelly K, Crowley J, Bunn PA Jr, Presant CA, Grevstad PK, Moinpour CM, Ramsey SD, Wozniak AJ, Weiss GR, Moore DF, Israel VK, Livingston RB, Gandara DR (2001) Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a southwest oncology group trial. J Clin Oncol 19(13):3210–3218. doi:10.​1200/​JCO.​2001.​19.​13.​3210 CrossRefPubMed
4.
Scagliotti GV, De Marinis F, Rinaldi M, Crinò L, Gridelli C, Ricci S, Matano E, Boni C, Marangolo M, Failla G, Altavilla G, Adamo V, Ceribelli A, Clerici M, Di Costanzo F, Frontini L, Tonato M (2002) Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 20(21):4285–4291. doi:10.​1200/​JCO.​2002.​02.​068 CrossRefPubMed
5.
6.
Sawabata N, Asamura H, Goya T, Mori M, Nakanishi Y, Eguchi K, Koshiishi Y, Okumura M, Miyaoka E, Fujii Y (2010) Japanese lung cancer registry study: first prospective enrollment of a large number of surgical and nonsurgical cases in 2002. J Thorac Oncol 5(9):1369–1375. doi:10.​1097/​JTO.​0b013e3181e452b9​ CrossRefPubMed
7.
Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Bálint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA (2015) Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol 16(7):763–774. doi:10.​1016/​S1470-2045(15)00021-2 CrossRefPubMed
8.
Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH (2006) Paclitaxel–carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355(24):2542–2550. doi:10.​1056/​NEJMoa061884 CrossRefPubMed
9.
Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C (2013) PARAMOUNT: final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol 31(23):2895–2902. doi:10.​1200/​JCO.​2012.​47.​1102 CrossRefPubMed
10.
Gao G, Ren S, Li A, Xu J, Xu Q, Su C, Guo J, Deng Q, Zhou C (2012) Epidermal growth factor receptor-tyrosine kinase inhibitor therapy is effective as first-line treatment of advanced non-small-cell lung cancer with mutated EGFR: a meta-analysis from six phase III randomized controlled trials. Int J Cancer 131(5):E822–E829. doi:10.​1002/​ijc.​27396 CrossRefPubMed
11.
Solomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J, Blackhall F (2014) First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med 371(23):2167–2177. doi:10.​1056/​NEJMoa1408440 CrossRefPubMed
12.
Seto T, Kiura K, Nishio M, Nakagawa K, Maemondo M, Inoue A, Hida T, Yamamoto N, Yoshioka H, Harada M, Ohe Y, Nogami N, Takeuchi K, Shimada T, Tanaka T, Tamura T (2013) CH5424802 (RO5424802) for patients with ALK-rearranged advanced non-small-cell lung cancer (AF-001JP study): a single-arm, open-label, phase 1-2 study. Lancet Oncol 14(7):590–598. doi:10.​1016/​S1470-2045(13)70142-6 CrossRefPubMed
13.
Tabchi S, Kourie HR, Kattan J (2016) Adding checkpoint inhibitors to tyrosine kinase inhibitors targeting EGFR/ALK in non-small cell lung cancer: a new therapeutic strategy. Investig New Drugs 34(6):794–796CrossRef
14.
Ku BM, Bae YH, Koh J, Sun JM, Lee SH, Ahn JS, Park K, Ahn MJ (2016) AZD9291 overcomes T790 M-mediated resistance through degradation of EGFR(L858R/T790M) in non-small cell lung cancer cells. Investig New Drugs 34(4):407–415CrossRef
15.
Peters S, Adjei AA, Gridelli C, Reck M, Kerr K, Felip E (2012) Metastatic non-small-cell lung cancer (NSCLC): ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 23(suppl 7):vii56–vii64. doi:10.​1093/​annonc/​mds226 CrossRefPubMed
16.
17.
18.
Suzuki S, Karayama M, Inui N, Fujisawa T, Enomoto N, Nakamura Y, Kuroishi S, Matsuda H, Yokomura K, Koshimizu N, Toyoshima M, Imokawa S, Asada K, Masuda M, Yamada T, Watanabe H, Suda T (2016) Continuation maintenance therapy with S-1 in chemotherapy- naïve patients with advanced squamous cell lung cancer. Investig New Drugs 34(4):490–496CrossRef
19.
Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF (2012) Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol 30(17):2055–2062. doi:10.​1200/​JCO.​2011.​39.​5848 CrossRefPubMed
20.
Furuse K1, Fukuoka M, Kurita Y, Ariyoshi Y, Niitani H, Yoneda S, Fujii M, Hasegawa K, Nishiwaki Y, Tamura M (1992) A phase II clinical study of cis-diammine glycolato platinum, 254-S, for primary lung cancer. Gan To Kagaku Ryoho 19(6):879–884PubMed
21.
Fukuda M, Shinkai T, Eguchi K, Sasaki Y, Tamura T, Ohe Y, Kojima A, Oshita F, Hara K, Saijo N (1990) Phase II study of (glycolate-O, O’) diammineplatinum(II), a novel platinum complex, in the treatment of non-small-cell lung cancer. Cancer Chemother Pharmacol 26(6):393–396CrossRefPubMed
22.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45(2):228–247. doi:10.​1016/​j.​ejca.​2008.​10.​026 CrossRefPubMed
23.
Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR, KEYNOTE-024 Investigators (2016) Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med 375(19):1823–1833CrossRefPubMed
24.
25.
Nakajima O, Inoue S, Kobayashi K (1994) Differences in intracellular uptake of cisplatin, carboplatin and 254-S among human lung cancer cell lines. Japan J Lung Cancer 34:313–319CrossRef
26.
Naito Y, Kubota K, Ohmatsu H, Goto K, Niho S, Yoh K, Ohe Y (2011) Phase II study of nedaplatin and docetaxel in patients with advanced squamous cell carcinoma of the lung. Ann Oncol 22(11):2471–2475. doi:10.​1093/​annonc/​mdq781 CrossRefPubMed
27.
Shukuya T, Yamanaka T, Seto T, Daga H, Goto K, Saka H, Sugawara S, Takahashi T, Yokota S, Kaneda H, Kawaguchi T, Nagase S, Oguri T, Iwamoto Y, Nishimura T, Hattori Y, Nakagawa K, Nakanishi Y, Yamamoto N (2015) Nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L): a randomised, open-label, phase 3 trial. Lancet Oncol 16(16):1630–1638. doi:10.​1016/​S1470-2045(15)00305-8 CrossRefPubMed
28.
Fang Y, Wang L, Xia GH, Shi MQ (2014) Clinical investigation of efficacy of albumin bound paclitaxel plus platinum compounds as first-line chemotherapy for stage III/IV squamous non-small cell lung cancer. Asian Pac J Cancer Prev 15(17):7453–7457CrossRefPubMed
29.
Ibrahim NK, Desai N, Legha S, Soon-Shiong P, Theriault RL, Rivera E, Esmaeli B, Ring SE, Bedikian A, Hortobagyi GN, Ellerhorst JA (2002) Phase I and pharmacokinetic study of ABI-007, a Cremophor-free, protein-stabilized, nanoparticle formulation of paclitaxel. Clin Cancer Res 8(5):1038–1044PubMed
30.
Gardner ER, Dahut WL, Scripture CD, Jones J, Aragon-Ching JB, Desai N, Hawkins MJ, Sparreboom A, Figg WD (2008) Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel. Clin Cancer Res 14(13):4200–4205. doi:10.​1158/​1078-0432 CrossRefPubMedPubMedCentral
31.
John TA, Vogel SM, Tiruppathi C, Malik AB, Minshall RD (2003) Quantitative analysis of albumin uptake and transport in the rat microvessel endothelial monolayer. Am J Physiol Lung Cell Mol Physiol 284(1):L187–L196. doi:10.​1152/​ajplung.​00152.​2002 CrossRefPubMed
32.
Desai N, Trieu V, Yao Z, Louie L, Ci S, Yang A, Tao C, De T, Beals B, Dykes D, Noker P, Yao R, Labao E, Hawkins M, Soon-Shiong P (2006) Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of Cremophor-free, albumin-bound paclitaxel, ABI-007, compared with Cremophor-based paclitaxel. Clin Cancer Res 12(4):1317–1324. doi:10.​1158/​1078-0432.​CCR-05-1634 CrossRefPubMed
33.
Metadaten
Titel
Phase I study of Nedaplatin, a platinum based antineoplastic drug, combined with nab-paclitaxel in patients with advanced squamous non–small cell lung cancer
verfasst von
Satoshi Igawa
Sakiko Otani
Yoshiro Nakahara
Shinichiro Ryuge
Yasuhiro Hiyoshi
Tomoya Fukui
Hisashi Mitsufuji
Masaru Kubota
Masato Katagiri
Yuichi Sato
Jiichiro Sasaki
Noriyuki Masuda
Publikationsdatum
02.05.2017
Verlag
Springer US
Erschienen in
Investigational New Drugs / Ausgabe 1/2018
Print ISSN: 0167-6997
Elektronische ISSN: 1573-0646
DOI
https://doi.org/10.1007/s10637-017-0472-x

Weitere Artikel der Ausgabe 1/2018

Acknowledgement of Reviewers 2017

  • ACKNOWLEDGEMENTS

The kinesin Eg5 inhibitor K858 induces apoptosis and reverses the malignant invasive phenotype in human glioblastoma cells

  • PRECLINICAL STUDIES

A Phase I study to determine safety, pharmacokinetics, and pharmacodynamics of ANF-RHO™, a novel PEGylated granulocyte colony-stimulating factor, in healthy volunteers

  • PHASE I STUDIES

A phase Ib study of everolimus combined with metformin for patients with advanced cancer

  • Open Access
  • PHASE I STUDIES

Outcomes and prognostic factors for relapsed or refractory lymphoma patients in phase I clinical trials

  • PHASE I STUDIES

A phase I dose-escalation study of the safety and pharmacokinetics of a tablet formulation of voxtalisib, a phosphoinositide 3-kinase inhibitor, in patients with solid tumors

  • PHASE I STUDIES

Neu im Fachgebiet Onkologie

Nierenzellkarzinom: Daten zur Lebensqualität unter HIF-Inhibition vorgelegt

Seit wenigen Wochen ist mit Belzutifan eine neue Wirkstoffklasse beim fortgeschrittenen klarzelligen Nierenzellkarzinom in der EU zugelassen. Frisch publizierte Ergebnisse zur Lebensqualität erweitern jetzt die Datenbasis zur Risiko-Nutzen-Bewertung für den HIF-2α-Inhibitor.

Warum genderspezifische Medizin notwendig ist 

Laut Zahlen der WHO aus dem Jahr 2024 sterben zwei Frauen pro Minute an Krankheiten, die mit geschlechtsspezifischen Faktoren zusammenhängen. Außerdem wirken Medikamente bei ihnen oft anders als bei Männern. Zeit für ein genderspezifisches Denken in der Medizin.

Nach Vollremission bei Ösophagus-Ca. – Operation erstmal aussetzen?

Studienziel erreicht, dennoch viele Fragen offen. So lassen sich die Ergebnisse der SANO-Studie zur Active-Surveillance versus sofortigen Ösophagektomie nach neoadjuvanter Komplettremission zusammenfassen. Interessant sind die Daten so oder so.

Mammakarzinom: Bluttest statt Gewebeprobe

Der Einsatz einer Liquid Biopsy reicht von der Prognose bis hin zum Nachweis eines molekularen Relapses bei Krebs. Welche Rolle sie künftig für therapeutische Entscheidungen spielt, wird aktuell intensiv erforscht.

Update Onkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.

Newsletter bestellen
Bildnachweise