FP01.01 The Association of Bevacizumab with a Decreased Risk of Brain Metastases in ECOG-ACRIN E1505 in Completely Resected Stage IB-IIIA NSCLC

7533 Background: It remains controversial whether completely resected elderly NSCLC patients should receive adjuvant chemotherapy (ACT) and with what treatment regimen. We previously reported from a SEER-Medicare analysis of cases diagnosed up to 2005, that carbo-ACT is given much more frequently than cis-ACT and both are associated with improved overall survival (OS). Since randomized ACT trials were published around 2005, an update is necessary to reflect more recent practice patterns. Methods: We identified 16,420 patients >65 years in the SEER-Medicare database with resected stage IB-IIIA NSCLC, diagnosed between 1992 and 2007. Among these patients, 1,803 (11%) received platinum-ACT. Propensity score methods and Cox regression analyses were used to assess survival outcomes, as well as to compare carbo- versus cis-based therapy, while controlling for potential confounders. Results: Among those receiving platinum-based ACT, of whom 83% received carbo, there was a significant OS survival advantage compared to those receiving no ACT (TABLE). Carbo-ACT is associated with similar OS as compared to cis-ACT. The carbo/paclitaxel doublet was the most commonly used regimen, given to 52%. Chemotherapy-related toxicities requiring hospitalization were comparable between carbo- and cis-ACT groups, except for significantly less dehydration and anemia among those receiving carbo-ACT. Conclusions: In community practice reflected in this SEER-Medicare study, a minority of completely resected stage IB-IIIA NSCLC received platinum-based ACT that is associated with improved OS. Carbo-ACT was given in a 5:1 ratio compared to cis-ACT, had comparable OS advantage, and a somewhat more favorable toxicity profile. [Table: see text]

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A randomized phase II trial of adjuvant chemotherapy with docetaxel (DOC) plus cisplatin (CIS) versus paclitaxel (PAC) plus carboplatin (CAR) in patients with completely resected non-small cell lung cancer (NSCLC): Safety and feasibility data from trial TORG 0503

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.7561 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 7561-7561

Author(s):

K. Kubota ◽

H. Kunitoh ◽

T. Seto ◽

N. Shimada ◽

M. Tsuboi ◽

...

Keyword(s):

Adjuvant Chemotherapy ◽

Sensory Neuropathy ◽

Standard Of Care ◽

Eligibility Criteria ◽

Stage Ib ◽

Randomized Phase Ii ◽

Secondary Endpoints ◽

Resected Stage ◽

Iiia Nsclc ◽

Ecog Ps

7561 Background: Adjuvant chemotherapy is standard of care for patients with completely resected stage IB, II and IIIA NSCLC. However, the optimum chemotherapy regimen has not been determined. TORG 0503 was conducted to evaluate platinum-based third generation regimens in this clinical setting. Methods: Patients with completely resected stage IB, IIA, IIB or stage IIIA NSCLC were stratified by stage (IB/IIA vs. IIB/IIIA) and institution and randomized to receive 3 cycles of DOC (60 mg/m2, day 1) plus CIS (80 mg/m2, day 1) or 3 cycles of PAC (200 mg/m2, day 1) plus CAR (AUC 6, day 1). Both regimens were repeated every 3 - 4 weeks. Other eligibility criteria included ECOG PS 0–1, age ≥20, and =<70 years old, adequate organ function, no prior chemotherapy or radiotherapy. Patients who underwent pneumonectomy were excluded. The primary endpoint was 2-year relapse free survival (RFS), and secondary endpoints were overall survival (OS), quality of life (QOL), feasibility and toxicity. Results: 111 patients were randomized between April 2006 and July 2008, 58 patients to DOC+CIS (DC) and 53 to PAC+CAR (PA). Patients’ demographics (DC/PA): median age 63/59 years, 60%/66% male, 17%/22% PS 1, 79%/73% adenocarcinoma, 40%/40% of patients were stage IB/IIA, 60%/60% IIB/IIIA. Feasibility: 93% (54/58) of patients allocated to DC and 92% (49/53) patients in the PA arm completed 3 planned cycles of chemotherapy. Toxicities: DC vs. PA: Grade (G) 3/4 neutropenia (86%/75%), G3/4 anemia (2%/0%). G 3 febrile neutropenia (10%/4%), G2 ALT (0%/10%), G2 creatinine (17%/0%), G2–4 allergy (0%/4%), G2 alopecia (43%/47%), G2/3 fatigue (5%/10%), G2/3 anorexia (43%/22%), G2/3 nausea (47%/22%), G2/3 vomiting (31%/12%), G2 diarrhea (12%/8%), G2 constipation (2%/4%), G2/3 sensory neuropathy (3%/33%), G2/3 arthralgia (0%/31%), G2 myalgia (2%/8%). No treatment related deaths were observed in either arm. Conclusions: Both docetaxel plus cisplatin and paclitaxel plus carboplatin are safe and feasible regimens as adjuvant chemotherapy. [Table: see text]

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IMpower010: Primary results of a phase III global study of atezolizumab versus best supportive care after adjuvant chemotherapy in resected stage IB-IIIA non-small cell lung cancer (NSCLC).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.8500 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 8500-8500

Author(s):

Heather A. Wakelee ◽

Nasser K. Altorki ◽

Caicun Zhou ◽

Tibor Csőszi ◽

Ihor O. Vynnychenko ◽

...

Keyword(s):

Supportive Care ◽

Primary Endpoint ◽

Early Stage ◽

Best Supportive Care ◽

Stage Ii ◽

Phase Iii ◽

Stage Ib ◽

Platinum Based Chemotherapy ◽

Resected Stage ◽

Iiia Nsclc

8500 Background: Adjuvant platinum-based chemotherapy (chemo) provides only a modest 5-year survival benefit in fully resected, high-risk early-stage NSCLC. We report the primary disease-free survival (DFS) results from the pre-planned interim analysis of IMpower010, a randomized phase 3 open-label trial of adjuvant atezolizumab (atezo; anti–PD-L1) vs best supportive care (BSC) after adjuvant chemo in patients (pts) with early-stage resected NSCLC. Methods: Eligible pts had completely resected (4-12 weeks prior to enrollment) Stage IB (≥4 cm)-IIIA NSCLC (AJCC/UICC v7) and ECOG PS 0-1. A total of 1280 pts were enrolled, and 1269 pts received up to four 21-day cycles of cisplatin-based chemo (plus pemetrexed, docetaxel, gemcitabine or vinorelbine). Of these pts (n=1269), 1005 were subsequently randomized 1:1 to 16 cycles of atezo 1200 mg Q3W or BSC. The primary endpoint of investigator-assessed DFS and secondary endpoint of overall survival (OS) were tested hierarchically: first DFS in the PD-L1 TC ≥1% (SP263) subgroup with Stage II-IIIA disease, then DFS in all randomized pts with Stage II-IIIA disease, then DFS in the ITT population (Stage IB-IIIA) and finally OS in the ITT population. Efficacy assessments were based on randomized pts. Safety was assessed in the safety-evaluable population, defined as pts who received ≥1 dose of atezo or who had ≥1 post-baseline safety assessment if randomized to the BSC arm. Results: At data cutoff (January 21, 2021), median follow-up was 32.2 months in the ITT population. Baseline characteristics were generally balanced between arms. Atezo showed statistically significant DFS benefit vs BSC in the PD-L1 TC ≥1% Stage II-IIIA and all randomized Stage II-IIIA populations; the significance boundary was not crossed for DFS in the ITT population (Table). OS data were immature and not formally tested. Pts in the atezo arm received a median of 16 (range, 1-16) atezo doses. Any-grade AEs occurred in 92.7% (atezo) and 70.7% (BSC); events were Grade 3/4 in 21.8% and 11.5%, respectively. Grade 5 treatment-related AEs occurred in 0.8% of pts in the atezo arm. AEs leading to atezo discontinuation occurred in 18.2% of atezo-treated pts. Conclusions: IMpower010 met its primary endpoint, showing DFS benefit with adjuvant atezo vs BSC after adjuvant chemo in pts with resected Stage II-IIIA NSCLC, with pronounced benefit in the PD-L1 TC ≥1% subgroup. The safety profile of atezo was consistent with prior experience of atezo monotherapy across indications and lines of therapy. Funding: F. Hoffmann-La Roche Ltd. Clinical trial information: NCT02486718. [Table: see text]

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