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Laryngeal Laryngeal Conservation Conservation Sarah Rodriguez, MD Sarah Rodriguez, MD Shawn Newlands, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy UTMB Dept of Otolaryngolgy Grand Rounds Grand Rounds February 2005 February 2005

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Page 1: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Laryngeal ConservationLaryngeal ConservationSarah Rodriguez, MDSarah Rodriguez, MDShawn Newlands, MDShawn Newlands, MD

UTMB Dept of OtolaryngolgyUTMB Dept of OtolaryngolgyGrand RoundsGrand RoundsFebruary 2005February 2005

Page 2: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

IntroductionIntroduction

Advanced stage glottic cancer traditionally Advanced stage glottic cancer traditionally has been treated with surgery, most often has been treated with surgery, most often total laryngectomy, and post-operative total laryngectomy, and post-operative radiation therapy (PORT)radiation therapy (PORT)

Several randomized trials have Several randomized trials have demonstrated the feasibility of organ demonstrated the feasibility of organ preservation in patients with advanced preservation in patients with advanced laryngeal and hypopharyngeal cancerlaryngeal and hypopharyngeal cancer

Page 3: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Landmark StudiesLandmark Studies

The Department of Veterans Affairs The Department of Veterans Affairs Laryngeal Cancer Study Group (1991)Laryngeal Cancer Study Group (1991)

The European Organization for Research The European Organization for Research and Treatment of Cancer (1996)and Treatment of Cancer (1996)

Radiation Therapy Oncology Group Trial Radiation Therapy Oncology Group Trial 91-11 (2003)91-11 (2003)

Page 4: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

VA StudyVA Study

Goal:Goal:

to investigate whether induction to investigate whether induction chemotherapy and definitive XRT with chemotherapy and definitive XRT with laryngectomy reserved for salvage for laryngectomy reserved for salvage for patients with stage 3 or 4 laryngeal cancer patients with stage 3 or 4 laryngeal cancer represented a better initial treatment represented a better initial treatment approach than total laryngectomy and approach than total laryngectomy and post-operative XRTpost-operative XRT

Page 5: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

VA study DesignVA study Design

Two arms (322 patients divided between Two arms (322 patients divided between groups):groups): Experimental armExperimental arm

Patients received two cycles of chemotherapy consisting of Patients received two cycles of chemotherapy consisting of cisplatin and fluorouracil; those found not to have at least a cisplatin and fluorouracil; those found not to have at least a partial response at the primary site went on to laryngectomy; partial response at the primary site went on to laryngectomy; the remainder received a third round of chemotherapy and the remainder received a third round of chemotherapy and the vast majority of these patients went on to definitive XRTthe vast majority of these patients went on to definitive XRT

Control armControl armPatients received total laryngectomy and standard post-Patients received total laryngectomy and standard post-operative radiation therapy (PORT)operative radiation therapy (PORT)

Page 6: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

VA study resultsVA study results

The larynx was preserved in 107 patients (64%) of those The larynx was preserved in 107 patients (64%) of those assigned to induction chemotherapyassigned to induction chemotherapy

59 underwent total laryngectomy: 30 prior to XRT and 29 after 59 underwent total laryngectomy: 30 prior to XRT and 29 after radiation (persistent disease present on planned endoscopy 12 radiation (persistent disease present on planned endoscopy 12 weeks after XRT)weeks after XRT)

Late salvage surgery required in 11 additional patients (80% of Late salvage surgery required in 11 additional patients (80% of these occurred in the year after treatment)these occurred in the year after treatment)

Salvage laryngectomy required more often in those with glottic Salvage laryngectomy required more often in those with glottic vs supraglottic CA (43 vs 31%); fixed vs mobile VCs (41 vs vs supraglottic CA (43 vs 31%); fixed vs mobile VCs (41 vs 29%); gross cartilage involvement vs no cartilage involvement 29%); gross cartilage involvement vs no cartilage involvement (41 vs 35%)--but all this not statistically significant(41 vs 35%)--but all this not statistically significant

Significantly, salvage surgery was required in 44 % of pts with Significantly, salvage surgery was required in 44 % of pts with stage IV cancers as compared with 29% of pts with stage 3 stage IV cancers as compared with 29% of pts with stage 3 cancer AND 56% of patients with T4 cancers as compared with cancer AND 56% of patients with T4 cancers as compared with 29% of patients with smaller primaries29% of patients with smaller primaries

Page 7: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Other VA study FindingsOther VA study Findings

The estimated two year The estimated two year survival was 68% for the survival was 68% for the induction chemotherapy group induction chemotherapy group and the surgery group. and the surgery group. No significant differences in No significant differences in survival between treatments survival between treatments when pts grouped according to when pts grouped according to tumor stage or site.tumor stage or site.Survival rates similar for Survival rates similar for chemotherapy responders and chemotherapy responders and non-respondersnon-respondersPatients in the induction Patients in the induction chemotherapy arm had a chemotherapy arm had a higher rate of local failure but a higher rate of local failure but a decreased rate of distant decreased rate of distant metastasesmetastases

Page 8: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

EORTC StudyEORTC Study

Goal:Goal:

To compare the results of treating To compare the results of treating patients with T2-T4, N0-N2b squamous patients with T2-T4, N0-N2b squamous cell carcinoma of the pyriform sinus or cell carcinoma of the pyriform sinus or aryepiglottic fold with either induction aryepiglottic fold with either induction chemotherapy followed by radiation or chemotherapy followed by radiation or standard surgical therapy and PORTstandard surgical therapy and PORT

Page 9: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

EORTC PatientsEORTC Patients

94 patients randomized to the immediate 94 patients randomized to the immediate surgery armsurgery arm100 patients randomized to the induction 100 patients randomized to the induction chemotherapy (cisplatin and fluorouracil) chemotherapy (cisplatin and fluorouracil) and XRT armand XRT armPatients in the induction chemo arm had to Patients in the induction chemo arm had to have a complete response in order to have a complete response in order to proceed to XRTproceed to XRT

Page 10: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

EORTC ResultsEORTC Results

Survival:Survival: Disease-free survival at 3 and 5 years Disease-free survival at 3 and 5 years

essentially the same for the chemotherapy essentially the same for the chemotherapy and immediate surgery arms: 43 and 25% for and immediate surgery arms: 43 and 25% for chemo arm and 32 and 27% for surgery armchemo arm and 32 and 27% for surgery arm

At three years the overall survival rates At three years the overall survival rates appeared to favor the chemotherapy arm; the appeared to favor the chemotherapy arm; the survival rates at 5 years were similar between survival rates at 5 years were similar between groups but this estimate based on small groups but this estimate based on small number of patients at risknumber of patients at risk

Page 11: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

EORTC Results, Laryngeal EORTC Results, Laryngeal PreservationPreservation

For the entire group of 100 patients randomized For the entire group of 100 patients randomized to induction chemotherapy, the rate of being to induction chemotherapy, the rate of being alive and having a functional larynx at 3 and 5 alive and having a functional larynx at 3 and 5 years was 28 and 17% respectivelyyears was 28 and 17% respectively

The 3 and 5 year rate of retaining a functional The 3 and 5 year rate of retaining a functional larynx in the patients who completed treatment larynx in the patients who completed treatment in the induction chemotherapy arm were 64% in the induction chemotherapy arm were 64% and 58% respectivelyand 58% respectively

Page 12: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

EORTC Observations and EORTC Observations and ConclusionsConclusions

The authors conclude that attempted larynx The authors conclude that attempted larynx preservation with induction chemotherapy is preservation with induction chemotherapy is acceptably safe with hypopharyngeal canceracceptably safe with hypopharyngeal cancer

Fewer distant mets and increased time to distant Fewer distant mets and increased time to distant mets in the chemotherapy armmets in the chemotherapy arm

Chemotherapy complete responders were more Chemotherapy complete responders were more frequent among those with T2 disease (82%) frequent among those with T2 disease (82%) than those with T3 (48%) or T4 (0%) diseasethan those with T3 (48%) or T4 (0%) disease

Page 13: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Summary of VA and EORTC Summary of VA and EORTC studiesstudies

Both trials suggest that organ preservation is Both trials suggest that organ preservation is possible in patients with advanced stage possible in patients with advanced stage laryngeal or hypopharyngeal cancer;laryngeal or hypopharyngeal cancer;The role of chemotherapy not elucidated; rates The role of chemotherapy not elucidated; rates of organ preservation in the VA trial similar to of organ preservation in the VA trial similar to published rates of organ preservation after published rates of organ preservation after radiation aloneradiation aloneDistant metastases appear to be decreased with Distant metastases appear to be decreased with chemotherapychemotherapySuggest that head and neck squamous cell Suggest that head and neck squamous cell carcinoma is sensitive to cisplatin and carcinoma is sensitive to cisplatin and fluorouracilfluorouracil

Page 14: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

RTOG 91-11RTOG 91-11

Goal:Goal:To investigate three radiation-based To investigate three radiation-based therapies in the treatment of stage 3 and therapies in the treatment of stage 3 and stage 4 laryngeal cancer: stage 4 laryngeal cancer: Induction cisplatin and fluorouracil followed by Induction cisplatin and fluorouracil followed by

XRT (identical to VA experimental arm XRT (identical to VA experimental arm protocol)protocol)

Concurrent chemoradiation with cisplatinConcurrent chemoradiation with cisplatin Standard radiotherapyStandard radiotherapy

Page 15: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

PatientsPatients

Eligible patients Eligible patients had stage 3 or 4 had stage 3 or 4 laryngeal cancer. laryngeal cancer. T1 primary tumors T1 primary tumors were ineligible as were ineligible as well as T4 tumors well as T4 tumors that penetrated that penetrated through cartilage through cartilage or more than 1 cm or more than 1 cm into the base of into the base of tongue.tongue.

Page 16: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

RTOG 91-11 ResultsRTOG 91-11 Results

The rate of laryngeal preservation at a median follow-up of 3.8 years The rate of laryngeal preservation at a median follow-up of 3.8 years was significantly higher among patients receiving radiotherapy with was significantly higher among patients receiving radiotherapy with concurrent cisplatin (84%) than among those receiving induction concurrent cisplatin (84%) than among those receiving induction chemotherapy followed by XRT (72%) or those receiving chemotherapy followed by XRT (72%) or those receiving radiotherapy alone (67%)radiotherapy alone (67%)Chemotherapy suppressed distant metastasesChemotherapy suppressed distant metastasesTwo and five year survival did not differ among treatment groupsTwo and five year survival did not differ among treatment groupsPatients who were treated with concurrent chemoradation had Patients who were treated with concurrent chemoradation had significantly fewer local failures than either induction chemotherapy significantly fewer local failures than either induction chemotherapy + XRT or radiotherapy alone+ XRT or radiotherapy aloneTwo and five year disease free survival estimatesTwo and five year disease free survival estimates

Arm one: 52 and 38%Arm one: 52 and 38% Arm two: 61 and 36%Arm two: 61 and 36% Arm three: 44 and 27%Arm three: 44 and 27%

Page 17: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Areas of InterestAreas of Interest

Timing of combined chemoradiotherapyTiming of combined chemoradiotherapyOther chemotherapeutic agentsOther chemotherapeutic agentsNew biologic agentsNew biologic agents EGFR monoclonal antibodiesEGFR monoclonal antibodies Targeting hypoxic cellsTargeting hypoxic cells

Altered radiation fractionation schedulesAltered radiation fractionation schedules Hyperfractionation: lower doses per fraction, more Hyperfractionation: lower doses per fraction, more

fractions per day; increased dose of radiation; same fractions per day; increased dose of radiation; same duration of therapy; reduces late toxicityduration of therapy; reduces late toxicity

Accelerated fractionation: same dose over a shorter Accelerated fractionation: same dose over a shorter period of time; increases acute toxicity; decrease period of time; increases acute toxicity; decrease tumor repopulationtumor repopulation

Page 18: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Quality of Life and Functional Quality of Life and Functional OutcomesOutcomes

If both surgery + PORT and If both surgery + PORT and chemoradiation yield good local control chemoradiation yield good local control and essentially equivalent survival rates, and essentially equivalent survival rates, what is the comparative quality of life for what is the comparative quality of life for the patient?the patient?

What kinds of functional outcomes can be What kinds of functional outcomes can be expected after aggressive organ expected after aggressive organ preservation protocols?preservation protocols?

Page 19: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

VA Study Revisited: Quality of LifeVA Study Revisited: Quality of Life

A 1998 follow-up to the VA study identified 25 surviving A 1998 follow-up to the VA study identified 25 surviving patients from the surgery + PORT group and 21 patients patients from the surgery + PORT group and 21 patients from the induction chemo + XRT group. Patients were from the induction chemo + XRT group. Patients were administered the University of Michigan Head and Neck administered the University of Michigan Head and Neck Quality of Life (HNQOL) instrument, the Medical Quality of Life (HNQOL) instrument, the Medical Outcomes Short-Form 36 (SF-36), and the Beck Outcomes Short-Form 36 (SF-36), and the Beck Depression Inventory (BDI)Depression Inventory (BDI)

Chemo/XRT patients had significantly better quality of life scores Chemo/XRT patients had significantly better quality of life scores on the SF-36 mental health domain and also had better HNQOL on the SF-36 mental health domain and also had better HNQOL pain scorespain scores

Patients with intact larynges had significantly better HNQOL Patients with intact larynges had significantly better HNQOL emotion scoresemotion scores

More patients in the surgery (28%) were depressed than in the More patients in the surgery (28%) were depressed than in the chemo/XRT group (15%)chemo/XRT group (15%)

Page 20: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Other Quality of Life StudiesOther Quality of Life Studies

Lee-PrestonLee-Preston 36 patients surveyed 3-12 months after treatment with radiotherapy only 36 patients surveyed 3-12 months after treatment with radiotherapy only

(24) total laryngectomy + PORT or salvage laryngectomy after XRT (12)(24) total laryngectomy + PORT or salvage laryngectomy after XRT (12) Functional Assessment of Cancer Therapy (FACT) with head and neck Functional Assessment of Cancer Therapy (FACT) with head and neck

subscale, Nottingham Health Profile and the Hospital Anxiety and subscale, Nottingham Health Profile and the Hospital Anxiety and Depression ScaleDepression Scale

Combined therapy patients had lower FACT head and neck scores Combined therapy patients had lower FACT head and neck scores (poorer QOL) with identified problems of dry mouth, swallowing, (poorer QOL) with identified problems of dry mouth, swallowing, breathing and communicationbreathing and communication

The two treatment groups showed no difference in anxiety but there was The two treatment groups showed no difference in anxiety but there was a trend towards greater depression in the combined therapy groupa trend towards greater depression in the combined therapy group

Results of the NHP show that scores were worse for those in the Results of the NHP show that scores were worse for those in the combined therapy group in all domains except pain. The differences combined therapy group in all domains except pain. The differences were statistically significant in the emotional reaction and social isolation were statistically significant in the emotional reaction and social isolation subscales.subscales.

Page 21: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Other Quality of Life StudiesOther Quality of Life Studies

HannaHanna EORTCQOL administered to 42 patients treated EORTCQOL administered to 42 patients treated

either with concurrent chemorad or surgery and either with concurrent chemorad or surgery and PORT for stage 3 or 4 laryngeal cancerPORT for stage 3 or 4 laryngeal cancer

No statistically significant differences in overall QOL No statistically significant differences in overall QOL scoresscores

Subscale analysis revealed a trend for pts in the Subscale analysis revealed a trend for pts in the surgery group to experience greater difficulties with surgery group to experience greater difficulties with social functioning relative to the chemorad groupsocial functioning relative to the chemorad group

Surgery pts reported significantly greater sensory Surgery pts reported significantly greater sensory disturbances, use of painkillers, and coughingdisturbances, use of painkillers, and coughing

Chemorad pts reported significantly greater problems Chemorad pts reported significantly greater problems with dry mouthwith dry mouth

Page 22: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Functional Outcomes/SpeechFunctional Outcomes/Speech

VA Study: patients who retained their larynx fared VA Study: patients who retained their larynx fared significantly better from the standpoint of speech significantly better from the standpoint of speech communication. communication.

At two years post-treatment, patients who retained their larynx At two years post-treatment, patients who retained their larynx had regained their pre-treatment level of functioning for two of had regained their pre-treatment level of functioning for two of the three measures tested (intelligibility and reading rate) and the three measures tested (intelligibility and reading rate) and exceeded pretreatment performance on the third ( a exceeded pretreatment performance on the third ( a communication profile used to assess general communication communication profile used to assess general communication status). status).

Laryngectomy patients had a decrease in all three measures Laryngectomy patients had a decrease in all three measures despite all options of speech rehabilitation and therapydespite all options of speech rehabilitation and therapy

RTOGRTOG No difference in treatment groupsNo difference in treatment groups The reporting of moderate or worse speech impairment was The reporting of moderate or worse speech impairment was

reported as 6, 11, and 13% at one year and 3, 6 and 8 percent reported as 6, 11, and 13% at one year and 3, 6 and 8 percent at two yearsat two years

Page 23: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Functional Outcomes/SwallowingFunctional Outcomes/Swallowing

RTOGRTOG At one year, 23% of those assigned to concurrent At one year, 23% of those assigned to concurrent

chemorad could swallow only soft foods or liquids and chemorad could swallow only soft foods or liquids and 3% could not swallow at all3% could not swallow at all

At one year only 9% of the induction chem/rad group At one year only 9% of the induction chem/rad group was limited to soft foods or liquids and there were no was limited to soft foods or liquids and there were no patients that could not swallow at all. This was similar patients that could not swallow at all. This was similar to the radiotherapy-only armto the radiotherapy-only arm

All three groups were similar at two years with 14-All three groups were similar at two years with 14-16% of patients reporting difficulty swallowing16% of patients reporting difficulty swallowing

Page 24: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Functional Functional Outcomes/SwallowingOutcomes/Swallowing

Gillespie recently reported a survey of pts 12 months or more out from Gillespie recently reported a survey of pts 12 months or more out from treatment of stage 3 or 4 SCCA of the oropharynx, larynx or hypopharynx. treatment of stage 3 or 4 SCCA of the oropharynx, larynx or hypopharynx. 19 patients were in the larynx/hypopharynx category. 11 of these were 19 patients were in the larynx/hypopharynx category. 11 of these were treated with surgery + PORT; 8 were treated with concurrent chemoXRTtreated with surgery + PORT; 8 were treated with concurrent chemoXRTMD Anderson Dysphagia Inventory was usedMD Anderson Dysphagia Inventory was used

Global subscale: pts perception of degree of swallowing impairmentGlobal subscale: pts perception of degree of swallowing impairment Emotional subscale: upset or embarassement by dysphagiasEmotional subscale: upset or embarassement by dysphagias Functional subscale: ease of food preparation and eating in publicFunctional subscale: ease of food preparation and eating in public Physical subscale: effect of dysphagia on dietary consistency, Physical subscale: effect of dysphagia on dietary consistency,

aspiration, weight maintenanceaspiration, weight maintenanceNo difference between in scores between treatment typeNo difference between in scores between treatment typeAll pts in study had scores 25-50% worse than the general populationAll pts in study had scores 25-50% worse than the general population

Page 25: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Functional Outcomes/Speech and Functional Outcomes/Speech and SwallowingSwallowing

Carrara de Angelis reports speech and swallow Carrara de Angelis reports speech and swallow evaluations of 19 patients who underwent evaluations of 19 patients who underwent concurrent chemoradiation with paclitaxel and concurrent chemoradiation with paclitaxel and cisplatin for larygeal or hypopharyngeal SCCAcisplatin for larygeal or hypopharyngeal SCCAAnalysis took place 2-9 mos post-treatmentAnalysis took place 2-9 mos post-treatment 11 pts with tracheostomy and 14 pts with feeding tube 11 pts with tracheostomy and 14 pts with feeding tube

at some point in treatmentat some point in treatment At time of analysis, 6 still had tracheostomy and 6 At time of analysis, 6 still had tracheostomy and 6

were still using a feeding tubewere still using a feeding tube

ResultsResults 40% of patients with moderate dysphonia, 27% 40% of patients with moderate dysphonia, 27%

severe dysphoniasevere dysphonia

Page 26: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

More Carrara de Angelis ResultsMore Carrara de Angelis Results

DYSPHAGIA SEVERITYDYSPHAGIA SEVERITY

1. Severe (feeding tube): unable to tolerate any oral contrast 1. Severe (feeding tube): unable to tolerate any oral contrast safelysafely

2. Moderate to severe (not permitted oral intake): maximum 2. Moderate to severe (not permitted oral intake): maximum assistance or use of strategies with partial oral contrast only assistance or use of strategies with partial oral contrast only (tolerates at least 1 consistency safely with total use of (tolerates at least 1 consistency safely with total use of strategies)strategies)

3. Moderate (modified diet and/or independence): total 3. Moderate (modified diet and/or independence): total assistance, supervision, or strategies, 2 or more diet assistance, supervision, or strategies, 2 or more diet consistencies restrictedconsistencies restricted

4. Mild to moderate (modified diet and/or independence): 4. Mild to moderate (modified diet and/or independence): intermittent supervision or cueing, 1 or 2 consistencies restrictedintermittent supervision or cueing, 1 or 2 consistencies restricted

5. Mild (modified diet and/or independence): distant supervision, 5. Mild (modified diet and/or independence): distant supervision, may need 1 diet consistency restrictedmay need 1 diet consistency restricted

6. Within functional limits or modified independence (normal 6. Within functional limits or modified independence (normal diet): patient may have mild delayed swallowing reflex, stasis diet): patient may have mild delayed swallowing reflex, stasis spontaneously cleared, and there is no penetration or aspirationspontaneously cleared, and there is no penetration or aspiration

7. Normal (normal diet): normal in all situations and the patient 7. Normal (normal diet): normal in all situations and the patient does not need strategies or extra timedoes not need strategies or extra time

Page 27: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Other Functional Outcome StudiesOther Functional Outcome Studies

StatonStaton Identified 45 patients available for follow-up 6 months after Identified 45 patients available for follow-up 6 months after

treatment with intra-arterial cisplatin and concurrent XRT for treatment with intra-arterial cisplatin and concurrent XRT for stage 3 or 4 laryngeal cancerstage 3 or 4 laryngeal cancer

Sixteen patients required a tracheostomy and/or gastrostomy Sixteen patients required a tracheostomy and/or gastrostomy (tracheostomy 13, gastrostomy 13, both 10)(tracheostomy 13, gastrostomy 13, both 10)

The only variable found to impact subsequent tracheostomy and The only variable found to impact subsequent tracheostomy and feeding tube requirement was vocal cord fixation. T4 status and feeding tube requirement was vocal cord fixation. T4 status and massive cartilage invasion both trended toward an association massive cartilage invasion both trended toward an association with laryngeal dysfunctionwith laryngeal dysfunction

Page 28: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Conclusions: Quality of Life and Conclusions: Quality of Life and Functional OutcomeFunctional Outcome

Existing studies are small groups measured on different instrumentsExisting studies are small groups measured on different instrumentsData on quality of life seem to favor chemoradiation for organ preservationData on quality of life seem to favor chemoradiation for organ preservationIf rates of disease control are equal, more weight should be given to individual patient factors in If rates of disease control are equal, more weight should be given to individual patient factors in determining treatmentdetermining treatmentWhat is the comparative quality of life in those that require surgical salvage?What is the comparative quality of life in those that require surgical salvage?More data is required on how many patients require long-term tracheostomy or gastrostomy after More data is required on how many patients require long-term tracheostomy or gastrostomy after chemoradiation and how these specific issues impact QOLchemoradiation and how these specific issues impact QOLMore data is required on swallowing function post-treatment to determine normal time course of More data is required on swallowing function post-treatment to determine normal time course of improvement and impact on QOLimprovement and impact on QOL

Page 29: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

Surgical Complications After Surgical Complications After Attempted Organ PreservationAttempted Organ Preservation

Danish StudyDanish Study 472 patients treated with post-irradiation salvage laryngectomies472 patients treated with post-irradiation salvage laryngectomies 89 fistulae lasting more than two weeks=rate of 19%89 fistulae lasting more than two weeks=rate of 19% The number of laryngectomies performed per year declined and the fistulae rate The number of laryngectomies performed per year declined and the fistulae rate

increased; risk of fistula in 1987 12% vs risk of fistula in 1997 of 30%increased; risk of fistula in 1987 12% vs risk of fistula in 1997 of 30%RTOGRTOG

No significant difference in the rate of systemic complicationsNo significant difference in the rate of systemic complications Fistulae developed in 25, 30 and 15% of patients in arms 1, 2 and 3 respectivelyFistulae developed in 25, 30 and 15% of patients in arms 1, 2 and 3 respectively

LavertuLavertu Compared complications of a group of patients treated for stage 3 or 4 head and Compared complications of a group of patients treated for stage 3 or 4 head and

neck SCCA with either XRT or concurrent chemo/XRTneck SCCA with either XRT or concurrent chemo/XRT 30 salvage procedures were done with total laryngectomy being part of the 30 salvage procedures were done with total laryngectomy being part of the

salvage procedure in 14salvage procedure in 14 Major complications included carotid artery rupture, fistula, and GI bleed (one of Major complications included carotid artery rupture, fistula, and GI bleed (one of

each in the radiotherapy-only group) AND sepsis, stroke and pharyngeal stenosis each in the radiotherapy-only group) AND sepsis, stroke and pharyngeal stenosis (one each in the chemo/rad group)(one each in the chemo/rad group)

Minor complications were not numerous and did not differ between groupsMinor complications were not numerous and did not differ between groups Author concludes that major and minor complications did not differ between Author concludes that major and minor complications did not differ between

groups and that morbidity rates for salvage surgery after aggressive organ groups and that morbidity rates for salvage surgery after aggressive organ preservation protocols was acceptablepreservation protocols was acceptable

Page 30: Laryngeal Conservation Sarah Rodriguez, MD Shawn Newlands, MD UTMB Dept of Otolaryngolgy Grand Rounds February 2005

ConclusionsConclusions

More patients with advanced disease can enjoy More patients with advanced disease can enjoy organ preservationorgan preservationWork is ongoing to define the ideal protocols for Work is ongoing to define the ideal protocols for organ preservationorgan preservationMore work needs to be done to define which More work needs to be done to define which patients are acceptable for aggressive organ patients are acceptable for aggressive organ preservation and what quality of life and preservation and what quality of life and functional outcomes they can expectfunctional outcomes they can expectRole of the surgeon is changingRole of the surgeon is changingMedical oncologist should come to tumor boardMedical oncologist should come to tumor board