Annual Meeting Proceedings Part 1 - American Society of Clinical ...

364s Head and Neck Cancer
5532 Poster Discussion Session (Board #23), Sat, 8:00 AM-12:00 PM and
12:00 PM-1:00 PM
Influence of extracapsular extension on lymph node staging for patients
with squamous cell carcinoma of the head and neck. Presenting Author:
Megan Ann Baumgart, Yale University School of Medicine, New Haven, CT
Background: Although extracapsular extension (ECE) is a known poor
prognostic factor in head and neck squamous cell carcinoma (HNSCC) and
recommended to be collected by the current AJCC manual, it currently does
not influence the final stage. We evaluated the prognostic impact of ECE in
4 primary sites. Methods: The Surveillance Epidemiology and End Results
(SEER) was queried for patients with squamous cell cancers of the oral
cavity (OC), oropharynx (OP), hypopharynx (H) and larynx (L), known ECE
status, M0, and diagnosed between 2004 and 2007. Survival curves were
estimated by the Kaplan-Meier and compared by Cox proportional hazards
models. Results: There were 23,384 patients meeting eligibility criteria,
including 14,664 (62.7%) N0, 6483 (27.7%) N� without ECE (NECE),
and 2237 (9.6%) with ECE. ECE was associated with decreased 3-year
overall survival (OS), compared to NECE, for all lymph node stages
including N1 (52% vs 61%, HR 1.32, p � 0.001), N2a (60% vs 76%, HR
1.82, p�0.001), N2b (44% vs 62%, HR 1.62, p�0.001), N2c (34% vs
47%, HR 1.43, p�0.001), N3 (31% vs 44%, HR 1.38, p�0.012). ECE
was also an independent poor prognostic factor for cancer in the OC (HR
1.43, p � 0.001), OP (HR 1.44, p � 0.001), H (HR 1.58, p � 0.01), and
L (HR 1.28, p � 0.01). The comparison between ECE and NECE with one
additional N degree showed no significant OS difference, except OP N1 and
H N2a ECE, where survival was inferior to OP N2a and H N2b NECE
respectively (Table). Conclusions: ECE is a significant predictor for poor
outcomes in HNSCC, with survival equivalent to one additional degree of N
involvement.
N2a NECE vs
N1 ECE
N2b NECE vs
N2a ECE
N2c NECE vs
N2b ECE
N3 NECE vs
N2c ECE
Oral cavity
(n�1,886)
HR 1.19 (0.78-1.8;
p�0.423)
HR 0.77 (0.45-1.31;
p�0.337)
HR 0.96 (0.71-1.29;
p�0.765)
HR 0.98 (0.60- 1.62;
p�0.950)
Oropharynx
(n�4,821)
0.42 (0.30- 0.60;
p��0.0001)
0.85 (0.58-1.23;
p�0.392)
1.22 (0.95-1.56;
p�0.124)
0.72 (0.50-1.03;
p�0.073)
Hypopharynx
(n�687)
0.69 (0.38-1.23;
p�0.208)
0.57 (0.34-0.98;
p�0.040)
1.35 (0.83-2.20;
p�0.222)
0.96 (0.47-1.98;
p�0.920)
Larynx
(n�1,346)
1.30 (0.73-32;
p�0.364)
0.63 (0.35-1.12;
p�0.113)
0.81 (0.57-1.15;
p�0.232)
1.09 (0.66, 1.78;
p�0.738)
5534 General Poster Session (Board #21B), Sat, 1:15 PM-5:15 PM
Phase II study of biweekly dose-intense docetaxel plus gemcitabine
(GEM/DOC) in patients with recurrent locoregional or metastatic head and
neck squamous cell carcinoma. Presenting Author: Ammar Sukari, Karmanos
Cancer Institute, Detroit, MI
Background: Patients with metastatic head and neck squamous cell
carcinoma (HNSCC) have a poor prognosis, limited treatment options, and
median survival of 6 to 9 months. Docetaxel and gemcitabine have both
shown activity in HNSCC. The optimal combination, dosing, and scheduling
of both drugs is, however, unknown. Thus, we investigated the efficacy
and safety of biweekly dose intense GEM/DOC in patients with recurrent
locoregional or metastatic HNSCC. Methods: An open-label, singleinstitution,
single-arm, phase II study was conducted for patients who were
previously treated with no more than two cytotoxic regimens. The patients
received docetaxel (60 mg/m2IV) and gemcitabine (3000 mg/m2 IV) on day
1. The treatments were repeated every 14 days (one cycle), until disease
progression or unacceptable toxicity. The primary end point was response
rate. RECIST-defined response was evaluated every 4 cycles and toxicities
were evaluated at each cycle. Results: A total of 36 patients were enrolled
(M:F 26:10; median age (range), 60 years (46-79); performance status
0-1) , 29 of whom were response-evaluable. The patients received a
median of 4 cycles (range 0-24). Of these 29 patients, none achieved
complete response (CR) and 6 demonstrated a partial response (PR). Thus,
the overall response rate was 21% (95% confidence interval [CI], 0.10 –
0.38). Ten patients had stable disease (SD), resulting in tumor control (CR
or PR or SD) in 16 of 29 patients (55%), whereas 13 patients (45%) had
disease progression. The median response duration was 3.2 months (80%
CI: 2.0 – 6.1 months). For all 36 patients, the median overall survival was
4.2 months (95% CI: 2.4 – 7.0 months). Myelosuppression was the most
common adverse event. Grade 3-4 neutropenia and anemia were observed
in 10 (30%) and 13 (39%) patients, respectively. None of these patients,
however, had febrile neutropenia or bleeding events, and there were no
treatment-related deaths. Conclusions: The combination of biweekly dose
intense GEM/DOC was tolerable and active regimen in patients with
recurrent locoregional or metastatic HNSCC. Our findings warrant further
investigation in a larger patient population.
5533 General Poster Session (Board #21A), Sat, 1:15 PM-5:15 PM
Longitudinal Oncology Registry of Head and Neck Carcinoma (LORHAN):
Analysis of African American patients. Presenting Author: David N. Hayes,
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC
Background: Previous retrospective analyses show poor outcomes for
African American (AA) patients with head and neck carcinoma (HNC). Such
racial disparities are not well understood, but patient (pt) demographics,
comorbidities, tumor site, and human papillomavirus (HPV) status are
suggested to play a role. Methods: The LORHAN registry was used to
identify pts �18 yrs of age with de novo, non-metastatic HNC, and a record
of survival time. This study evaluated pt and treatment characteristics by
race, and conducted adjusted Cox regression analyses of overall survival
(OS) and progression-free survival (PFS) to identify prognostic factors and
interactions, and estimate hazard ratios (HRs) of AA vs. non-Hispanic white
(NHW). Results: Baseline pt characteristics (see table below). The median
OS/3-yr rate was 41.7 mo/51% in AA vs. 52.9 mo/70% in NHW,
(age-adjusted HR: 1.73 [95% CI: 1.45, 2.08]). The median PFS/3-yr rate
was 29.6 mo/43% in AA and 49.9 mo/62% in NHW, (age-adjusted HR:
1.64 [95%CI: 1.40, 1.93]). Multivariate analysis of OS and PFS showed
that AA race, stage III and IV, PS 2, and smoking were significantly
associated with a worse HR, while OP demonstrated a favorable HR over
other sites. Significant interaction tests led to subgroup analyses for OS
showing an elevated risk in AA with OP (HR: 2.62 [95%CI: 1.95, 3.52])
and similar risk elevations in male AA as well as in AA with PS 0-1 when
compared to NHW in the corresponding subgroups. Conclusions: Controlling
for other factors like PS and smoking, a worse prognosis was seen in AA
males with OP localized SCCHN. Further investigation to improve the
outcomes in this population is warranted.
AA
n�385
NHW
n�2,733 p value
Age Yrs, mean (SD) 58.9 (10.1) 59.8 (10.8) 0.13
Sex Male 295 (76.6%) 2,143 (78.4%) 0.43
Smoking Yes 341 (88.6%) 2,133 (78.1%) �0.0001
Alcohol Yes 331 (86.0%) 2,278 (83.4%) 0.19
Site Hypopharynx 32 (8.3%) 102 (3.7%) �0.0001
Larynx 134 (34.8%) 549 (20.1%)
Oral cavity 43 (11.7%) 439 (16.1%)
Oropharynx (OP) 143 (37.1%) 1,290 (47.2%)
Stage I, II 155 (41.5%) 1,399 (52.1%) �0.0001
III, IV 218 (59.3%) 1,284 (47.8%)
PS 0, 1 308 (80.4%) 2,496 (91.7%) �0.0001
HPV test in OP
patients only
Completed 21 (25.3%) 194 (24.1%)
HPV result in OP
patients only
Pos 8 (38.1%) 159 (82.4%) �0.0001
5535 General Poster Session (Board #21C), Sat, 1:15 PM-5:15 PM
An open-labeled, multicentric clinical study of cetuximab combined with
intensity-modulated radiotherapy (IMRT) plus concurrent chemotherapy in
locoregionally advanced (LA) nasopharyngeal carcinoma (NPC): A 2-year
follow-up report. Presenting Author: Chun-yan Chen, Cancer Center, Sun
Yat-sen University, Guangzhou, China
Background: To evaluate the safety and efficacy outcomes of concurrent
cetuximab plus IMRT and cisplatin in Chinese patients with LA NPC.
Methods: Patients with primary stage III-IVb (UICC/AJCC 2002 staging
system) and non-keratinizing NPC were enrolled in this prospective,
multicentric, phase II study. Cisplatin (80mg/m2 ,q3week) and cetuximab
(400mg/m2 one w before radiation, and then 250mg/m2 /w) were given
concurrently. The prescription dose of IMRT to GTVnx (primary tumor in
nasopharynx) was 66 Gy - 75.9 Gy, GTVnd (positive cervical lymph nodes)
was 60 Gy - 70Gy, The response rate was evaluated according to RECIST
1.0 criteria, and adverse events (AEs) were graded according to NCI CTCAE
V3.0 criteria. Results: From July 2008 to April 2009, 100 patients were
enrolled (74 male), with median age of 43 years. The proportion of stage
III, IVa and IVb patients were 71%, 22% and 7% respectively. 99% of
enrolled patients completed the planned treatment. AEs were within the
expected range and manageable. No toxic death occurred during the
treatment. Acneiform skin eruptions, mucositis, in-field dermatitis, xerostomia
and neucopenia were the most common seen AEs, with 64% grade 2/3
acneiform eruptions, 26% grade 2/3 in-field dermatitis, 90% � grade 2
mucositis (2 cases of grade 4 mucositis with spontaneous bleeding), 40%
� grade 2 xerostomia and 8% grade 2/3 neucopenia. With a median
follow-up time of 23.5 months, the 2 year overall survival (OS), disease-free
survival (DFS), local recurrence-free survival, regional (cervical lymph
node) recurrence free survival and distant metastasis-free survival rates for
the ITT population were 91%, 89%, 90%, 90% and 89%, respectively
Multivariate analysis showed that N stage was the only prognostic factor for
OS (p�0.0392, HR�2.946) and DFS (p�0.0062, HR�4.246) in these
patients. Conclusions: Cetuximab combined with IMRT plus concurrent
cisplatin in patients with LA NPC shows satisfactory 2-year locoregional
control rate and 2-year overall survival. The combination seems to be well
tolerated with a manageable side-effect profile.
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