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Induction chemotherapy following simultaneous radio/chemotherapy versus induction chemotherapy and radiotherapy alone in inoperable NSCLC (Stage IIIA/IIIB)

Reviewer: Neha Vapiwala, MD
OncoLink
Ultima Vez Modificado: 1 de junio del 2003

Presenter: R. M. Huber
Presenter's Affiliation: University of Munich, Germany; BROCAT-Group
Type of Session: Scientific

Background

Studies of inoperable NSCLC patients have previously shown a small but statistically significant advantage in median survival with combined modality treatment, ie: chemoradiation. This appears to hold true for both sequential and concurrent modality regimens. Data suggests that concurrent chemoradiation may be superior to induction chemotherapy followed by radiation, but at the possible costs of increased toxicity and logistical difficulty. This study aimed to determine whether induction chemotherapy followed by concurrent chemoradiation is superior to induction chemotherapy followed by radiation alone in pts with unresectable NSCLC.

Materials and Methods

• 303 pts underwent 2 cycles of induction chemotherapy with carboplatin and paclitaxel
• 84 pts omitted secondary to incomplete chemotherapy course, disease progression, death
• 219 pts with Stage IIIA/IIIB NSCLC randomized to one of two arms following induction chemotherapy
• Arm I = (115 pts) thoracic radiation to 60 Gy
• Arm II = (104 pts) above + simultaneous weekly paclitaxel
• Median follow-up = 9.9 mos
• Mean pt age = 61.5 y
• Endpoints of survival, time to progression, response to chemotherapy, and toxicity
• Trial designed to detect increase in median survival from 12 to 18 mos or in one-yr survival from 50 to 63%

Results

• Median survival RT alone vs. RT + chemo 14.8 mos vs. 20.2 mos
• Time to progression approximately ~5 mos longer in concurrent arm
• Complete response rates follwing randomized tx RT alone vs. RT + chemo 6.5% vs. 15.8%
• Comparable toxicity profiles

Author's Conclusions

• Induction chemotherapy followed by concurrent chemoradiation appears to have an accepatble toxicity profile.
• The toxicities are not statistically significantly different from induction chemotherapy followed by radiation alone.
• A higher complete response rate and less progressive disease was seen in the chemo--> chemoRT group.
• Time to progression was statistically significantly longer in chemo--> chemoRT group.
• Survival analysis is not yet mature enough to show any statistically significant survival difference.

Clinical/Scientific Implications

Induction chemotherapy followed by concurrent chemoradiation may play a role in the treatment paradigm for unresectable NSCLC (stage IIIA/IIIB) patients. This regimen appears to be well tolerated in some patients compared to sequential chemotherapy and radiation. However, a significant number of patients were dropped from the study prior to randomization which can lead to significant bias. Because of this, an intent to treat analysis is not performed. Thus after induction chemotherapy, only the most fit patients who did not progress went on to randomization. This must be remembered when the data presented is considered. Futures studies are warranted to evaluate this regimen.

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.