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A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 squamous-cell non-small cell lung cancer.

PIT-2

45

Median age of 43 enrolled patients was 66 years including 39 men (91%) and 40 smokers (93%). Clinical stage was as follows: T factor (T1a 2, T1b 9, T2a 20, T2b 4, and T3 8), and N factor based on CT scan (cN0-1 1, single cN2 29, and multiple cN2 13). Pathological confirmation of mediastinal lymph node metastasis (pN2) was required before registration.

Between December 2013 and September 2018, 45 patients from 16 Japanese institutions were enrolled in the PIT-2 trial. Among them, 43 (96%) patients received induction therapy and 39 (91%) underwent surgery.

No new treatment-related adverse events occurred during the induction therapy. Grade 4 hematological toxicities included leukopenia (2%), neutropenia (9%), anemia (2%), and hypertriglyceridemia (2%). Grade 4 non-hematological toxicities included colon perforation (2%) and QT prolongation (2%). No treatment-related deaths occurred during induction therapy. Severe surgical complications included grade 3 supraventricular arrhythmia (3%), grade 3/4 pneumonia (5%), grade 3 pleural effusion (5%), grade 3 bronchopleural fistula (5%), grade 3 empyema (3%), wound infection (3%), thromboembolism (3%), and anemia (3%). One 90-day postoperative mortality occurred in a patient who underwent right pneumonectomy and developed pneumonia after discharge.

The 2-year PFS and OS rates were 67% (90% CI, 54-78%) and 70% (95% CI, 53-81%), respectively. The treatment protocol was considered useful because the lower bound of CI exceeded the threshold of 40%.

PIT-2 trial showed that S-1 + cisplatin with concurrent thoracic radiotherapy followed by surgery is a safe and effective treatment strategy for patients with stage IIIA (N2) lung squamous cell carcinoma.

Dec. 02, 2024

Sept. 12, 2022

https://doi.org/10.1245/s10434-022-12490-4

No

No

https://jrct.niph.go.jp/latest-detail/jRCTs031180403

Suzuki Kenji

Juntendo University Hospital

3-1-3, Hongo, Bunkyo-ku, Tokyo

kjsuzuki@juntendo.ac.jp

Takamochi Kazuya

Juntendo University Hospital

3-1-3, Hongo, Bunkyo-ku, Tokyo

+81-3-3813-3111

ktakamo@juntendo.ac.jp

Complete

Dec. 01, 2013

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

(1) Histologically or cytologically proven squamous cel carcinoma of the lung, diagnosed using specimen material
(2) Stage IIIA- pathologically proven N2 disease
(3) Without previously treatment for lung cancer
(4) 20 years or more , 75 years or less
(5) ECOG PS 0-1
(6) Expected FEV 1.0 > 800ml after lung resection , SpO2 (Room air) >95%
(7) Adequate organ function
(8) Written informed consent

(1) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
(2) Under administration of flucytosine
(3) History of active infection
(4) Hepatitis Bs antigen positive
(5) History of severe heart disease
(6) Traumatic fracture of un recovery
(7) Severe diarrhea
(8) Severe drug allergy
(9) Investigational new drug or the unapproved drug is administered
(10) Interstitial pneumonia or pulmonary fibrosis detectable on chest CT
(11) History of active double cancer
(12) History of pregnancy or lactation
(13) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator

Both

Primary lung cancer

The surgical resection is performed after 3 cycles of induction concurrent chemoradiotherapy with CDDP, TS-1 and RT45Gy (1.8Gy/fra/day, 25fractions).

Mediastinal lymph node metastasis, Squamous cell carcinoma

Induction chemoradiotherapy, Surgery

2-year progression-free survival

- 5-year progression-free survival
- 2-year and 5-year overall survival
- Completion rate of the protocol treatment
- Complete resection rate
- Radiological response rate
- Down staging rate
- Safety
- Pathological response (Ef)
- Tumor markers (CEA/CYFRA)
- SUVmax on FDG-PET scan

+81-4-7133-1111

Mar. 14, 2019

none