Primary Chemotherapy (PCT) For Patients With Operable Oral Cavity Cancer: Results Of A Randomized Study

Diana Stripp, MD

University of Pennsylvania Cancer
Last Modified: May 13, 2001

Presenter: Lisa Licitra
Affiliation: Istituto Nazionale Tumori, Milan, Italy


    This study was designed to investigate the impact of neoadjuvant chemotherapy on primary surgery in operable oral cavity cancer.

Materials and Methods:

  1. Randomized trial of 195 patients with operable squamous cell carcinoma of the oral cavity comparing pCT followed by surgery ± RT (arm A) with surgery ± RT (arm B).
  2. Chemotherapy consisted of Cisplatin 100 mg/m2 day 1 and 5-Fluorouracil 1000 mg/m2 day 1-5 for 3 cycles.
  3. RT was performed in case of positive surgical margins, soft tissue invasion, more than 3 pathological nodes and/or extracapsular spread.


  1. Distribution by stage was similar in each group
  2. Chemotherapy was stopped for toxicity (12 pts), no response (11 pts), refusal (3 pts), protocol violation (1 pt). Three toxic deaths occurred in arm A, due to: cardiotoxicity (2 pts), sepsis (1 pt). Surgical morbidity was similar in both arms.
  3. Histologically positive surgical margins were found in 4% of pts in arm A and 12% in arm B.
  4. Eighty-two pts were evaluable for pathological response to pCT. Complete pathological response (pCR) was observed in 27% of pts and small foci of residual tumor (near pCR) were detected in 18%.
  5. Postoperative radiotherapy was performed in arm A 33% and arm B 46% of pts.
  6. The 5-yr survival was arm A 54% (95% C.I: 44- 65 %) and arm B 55% (95% C.I: 44-65 %). DFS was similar in both arms. Patients in near pCR or pCR had a 5 yr DFS of 88% comparing to 58% of cases not achieving it.
  7. Transmandibular surgery was performed in 44% of arm A and 62% of arm B pts.

Authors' Conclusions

  1. Primary chemotherapy did not improve survival of surgery ± RT in operable oral cavity cancer.
  2. The improved DFS of patients with major pathological response may be due to chemotherapy activity and/or to its selecting ability of good prognosis tumors.
  3. Chemotherapy appeared to allow less aggressive surgery to be performed on patients

Clinical/Scientific Implications:

    A less aggressive surgical procedure may allow organ preservation and improve cosmetic outcomes. However, further studies will be needed to evaluate the impact of neoadjuvant chemotherapy to primary surgery or to definitive radiation.

OncoLink ASCO 2001 coverage is provided by an unrestricted educational grant from Amgen