Table 2.
University of Michigan Protocols Involving Chemoselection with One Cycle of Induction Cisplatin^ and Fluorouracil (PF) to Select Patients for Organ Preservation
| Study | N | Median F/U | Patient Population | Definitive Therapy after Induction PF × 1c | Primary Tumor Response to Induction PF × 1c | % Organ Preservation | DFS | OS |
|---|---|---|---|---|---|---|---|---|
| UMCC 9520 [31] | 97 | 42 mo | Larynx SCCA; Operable stage III/IV |
(a)If PR* → CRT* → adjuvant PF × 2c (b)If < PR* → TL + PORT |
PR = 75% | 70% (all pts) 86% (CRT subset with PR after PF × 1c) |
78% (3y) | 85% (3y) |
| UMCC 0056 [34] | 32 | 45 mo | Larynx & hypopharynx SCCA; Operable stage III/IV |
(a)If CR* → alternating cycles PF & docetaxel (total 8c, including induction PF × 1c) (b)If PR* → CRT* → adjuvant PF × 2c (c)If < PR* → TL + PORT |
CR = 13% (4 pts) PR = 75% (24 pts) < PR = 13% (4 pts) |
78% (all pts) | 78% (3y - all pts) 0% (chemo alone for CR pts) |
68% (3y - all pts) 25% (chemo alone after CR pts) |
| UMCC 9921 Oropharyn × [43] | 66 | 64 mo | Oropharynx SCCA; Operable stage III/IV |
(a)If PR* → CRT → adjuvant paclitaxel × 2c (b)If < PR → Salvage surgery + PORT |
PR = 82% | 73% (all pts) | 76% (4y) | 70.4% (4y) |
| UMCC 9921 Oral Cavity [45] | 19 | 78 mo | Oral Cavity SCCA; Operable stage III/IV |
(a)If PR* → CRT → adjuvant paclitaxel × 2c (b)If < PR → Salvage surgery + PORT |
PR = 58% | 16% (all pts) 30% (CRT subset with PR after PF × 1c) |
46% (5y) | 32% (5y) |
Carboplatin (AUC =6) substituted for cisplatin 100 mg/m2 in patients not eligible for cisplatin
Tumor response assessed by direct laryngoscopy with bidirectional tumor measurements and primary tumor biopsies, performed under anesthesia 3 weeks after induction chemotherapy. Complete response was defined as clinical and histological absence of residual tumor. Partial response was defined as >50% reduction in bidimensional product of the primary tumor
Concurrent Chemoradiotherapy consisted of daily fractionated RT to 70 Gy in 35 fractions to the gross tumor volume, with concurrent cisplatin 100 mg/m2 on days 1, 22, and 43 (carboplatin AUC =6 substituted for patients not eligible for cisplatin)
C = chemotherapy cycles; CR = complete response; CRT = concurrent chemoradiotherapy; DFS = disease-free survival; F/U = follow-up; OS = overall survival; PF = cisplatin and fluorouracil; PORT = postoperative radiotherapy; PR = partial response; TL = total laryngectomy; UMCC = University of Michigan Cancer Center